search
Back to results

Complications After Lower Third Molar Surgery

Primary Purpose

Postoperative Complications, Antibiotic Reaction, Antibiotic Side Effect

Status
Active
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Moxifloxacin 400 mg Oral Tablet
Cefixime 400 mg Oral Tablet
Placebo
Sponsored by
University of Novi Sad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Molar, Third; Moxifloxacin; Cefixime; Placebo, Postoperative Complications; Antibiotic Prophylaxis, Drug Resistance; Microbial Sensitivity Tests

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients ≥18 years, indicated for surgical removal of the impacted mandibular third molars, with good systemic health (patients classified as ASA I and ASA II) were included in the study.

Exclusion Criteria:

  • hypersensitivity to study drugs; history of systemic antibacterial therapy within 6 months prior to randomization; pregnancy or breastfeeding; fluoroquinolone-related tendon disorder; clinically relevant cardiac conditions or QT interval prolonging drugs; severe hepatic insufficiency (Child-Pugh C). Also, criteria for not including the patients in the study were cases where, in addition to removing the impacted mandibular third molar, some other oral surgical procedure was performed, as well as patients with currently present pericoronitis.

Sites / Locations

  • Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Active Comparator: The first tested group

Active Comparator: The second tested group

Placebo Comparator: The control group

Arm Description

Patients orally received film-coated tablets with either 400 mg of moxifloxacin. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

Patients orally received film-coated tablets with either 400 mg of cefixime. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

One third of patients received placebo-tablets containing indifferent substances with no antimicrobial action (99% microcrystalline cellulose, 0.5% silicon dioxide and 0.5% magnesium stearate, which were of the same colour and overall appearance as the used antibiotics. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

Outcomes

Primary Outcome Measures

Rate of postoperative infection at the surgical site (SSI)
Signs of postoperative infection were registered clinically, based on the presence of local signs of inflammation and general signs of intoxication (elevated body temperature, accelerated erythrocyte sedimentation, leucocytosis, the level of C-reactive protein, etc. ).

Secondary Outcome Measures

Dry socket (alveolar osteitis)
The dry socket (alveolar osteitis) was diagnosed based on reported severe pain in the wound area, accompanied by specific local clinical appearance of the operative wound and absence of pus.
Postoperative pain assessed by visual analogue scale (VAS)
The postoperative pain was assessed using a visual analogue scale (VAS). VAS represents a horizontally drawn length of 100 mm, the beginning of which indicates a pain-free state on the left side, and the end on the right side the state of the strongest pain imaginable. All patients, by placing a dash on the scale, indicated the intensity of pain that, on the appropriate day in the postoperative period, they felt in its strongest intensity. The intensity of pain was determined by measuring the distance of the marked place on the scale from the beginning of the scale on the left side and expressed in millimeters.
Postoperative swelling (oedema)
The postoperative swelling (oedema) coefficient was obtained by measuring the preoperative and postoperative distance between specific reference points in millimetres. The reference points were: the outer corner of the eye and the angle of the lower jaw; lip corner and tragus; and chin tip and tragus.
Postoperative trismus (maximum inter-incisal opening of mouth)
The degree of postoperative trismus was assessed by measuring the distance between mesio-incisal angles of the upper and lower central incisors at the maximum mouth opening ability.
Postoperative pain assessed by verbal rating scale (VRS)
The postoperative pain was assessed using a verbal rating scale (VRS). VRS involves a numerical assessment of pain intensity based on six degrees (1-6) - no pain, barely sensitive pain, mild pain, moderate pain, severe pain and very strong, almost unbearable pain.
Postoperative pain assessed by number of analgesics
In each patient, the moment of postoperative pain, its intensity at the indicated observation times was registered, and the need for additional analgesics was registered (patients recorded the number of analgesics consumed daily from the completed surgical intervention to suture removal in the postoperative pain monitoring protocol).

Full Information

First Posted
July 27, 2021
Last Updated
June 14, 2022
Sponsor
University of Novi Sad
search

1. Study Identification

Unique Protocol Identification Number
NCT05027893
Brief Title
Complications After Lower Third Molar Surgery
Official Title
Efficacy of the Application of Moxifloxacin and Cefixime in Reduction of Inflammatory Sequelae and Complications After Mandibular Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Surgical removal of impacted mandibular wisdom teeth is a frequent intervention, usually accompanied by unpleasant sequelae (pain, swelling and trismus) in the postoperative period, sometimes even with possibly serious complications (dry socket/alveolar osteitis and postoperative infection at the surgical site - SSI). It is therefore advisable to use various medications and procedures to prevent or alleviate the occurrence of these sequelae and complications. Accordingly, there is a debate in the literature on the expedience of perioperative (prophylactic) use of antibiotics. It is interesting that numerous articles recommending perioperative (prophylactic) antibiotic use to patients undergoing the impacted mandibular third molar surgery may be found, as well as those providing arguments for the disagreement with such an approach, considering that its benefits do not outweigh the risks of adverse side effects, especially due to growing resistance of microorganisms towards antibiotics, which is a possible serious threat to global health. Concerning the perioperative (prophylactic) use of antibiotics for this indication, consensus has not yet been reached, and neither of the views has been verified by convincing scientific evidence. Having the aforementioned dilemma in mind, the main endpoint of the study was to determine the validity of perioperative (prophylactic) use of antibiotics as to alleviate customary sequelae and possible complications after surgical removal of impacted mandibular third molars and, at the same time, the effectiveness of newer antibiotics (moxifloxacin and cefixime) when used for this purpose. Moreover, microbiological investigations of susceptibility of the isolated microorganisms to antibiotics used in this research were performed, which could verify the clinically obtained results. With this in mind, two major contributions, based on scientifically verified results, could be expected from the research: (1) confirmation or refuting the validity of perioperative (prophylactic) antibiotic use to control sequelae or complications that could follow the impacted mandibular third molar surgery; and (2) confirmation of the efficacy of fluoroquinolones (moxifloxacin) and cephalosporins (cefixime) in controlling odontogenic infections.
Detailed Description
Clinical research was conducted at the Oral Surgery Department of the Dental Clinic of Vojvodina, Novi Sad, Serbia, adopting the double-blind prospective clinical study design. Microbiological studies were performed at the Center for Microbiology of the Institute of Public Health of Vojvodina, Novi Sad, Serbia, on swab samples obtained from the surgical wounds of patients with postoperative infection or the exudate (pus) obtained from the peri-coronal space of patients with pericoronitis or history of pericoronitis. The susceptibility of isolated microorganisms to moxifloxacin, cefixime and other antibiotics commonly used in oral & maxillofacial surgery (penicillin and its derivatives, erythromycin, azithromycin, clindamycin and tetracycline) was tested microbiologically. Patients ≥18 years, indicated for surgical removal of the impacted mandibular third molars, with good systemic health - patients classified as American Society of Anesthesiologists (ASA) classification of Physical Health is a grading system for preoperative health of the surgical patients - ASA I and ASA II were included in the study. Evaluation of the effects of the applied medication was performed on the basis of postoperative sequelae or complications. Complications, including dry socket/alveolar osteitis (AO) and postoperative infection at the surgical site (SSI), and inflammatory sequelae - pain, swelling and trismus (limited mouth opening), were evaluated postoperatively. In the case of pericoronitis or a history of pericoronitis, with the presence of exudate or pus, as well as in the case of postoperative infection, a swab was taken from the operative wound or pericoronary space, and the punctate of exudate or pus was sent for microbiological analysis. The main goal of this analysis was to establish the susceptibility of microorganisms not only to antibiotics used in this study, but also to antibiotics, which are the "gold standard" in the treatment of odontogenic infections, as well as other commonly used antibiotics in the treatment. Analyses were performed by standard bacteriological techniques (seeding the material on appropriate nutrient media and incubating them at 35-37 °C for 18-24 h) to isolate the bacteria. Identification of bacterial species was performed by classical bacteriological methods (morphological, cultural and physiological-biochemical), as well as by the automated system Matrix Assisted Laser Desorption Ionization - Time of Flight (MALDI-TOF), Germany. After identification, susceptibility testing of isolated bacterial species to antimicrobial drugs was performed by standard disk-diffusion method according to Kirby-Bauer, Mueller-Hinton agar and blood Mueller-Hinton agar (HiMedia, India), depending on which bacterial species was in question in line with European Committee on Antimicrobial Susceptibility Testing (EUCAST) or Clinical & Laboratory Standards Institute (CLSI) Guidelines. Discs from Bio-Rad, France, were used to perform the microbiological analyses. All surgical interventions were performed under local anesthesia, using 2% lidocaine with adrenaline 1: 80,000 in a total 4 ml volume (2 ml solution for injection contained 40 mg lidocaine hydrochloride in the form of lidocaine hydrochloride monohydrate and 0.025 mg adrenaline in the form of adrenaline tartrate: Lidocaine 2% - adrenaline, 40 mg +0.025. In all patients, the surgery involved a triangular mucoperiosteal flap design, sutured using synthetic poly-filament non-resorptive suture material (3-0). Patients were advised to take an analgesic containing 200 mg ibuprofen and 325 mg acetaminophen. In accordance with known ethical principles and in accordance with the principles of Good Clinical Practice (GCP), care for the well-being of the patients was maximally respected, in accordance with the latest revision of the Declaration of Helsinki and accepted principles that apply to clinical trials on humans. The holder of the protection of the patients in this clinical trial was the principal researcher, who cooperated with the Ethics Committee of the Dental Clinic of Vojvodina, University of Novi Sad. The patients written Informed Consent implied that the patient had received full information about the research, and was stressed that they had the right to decide independently to participate, without coercion and external influences, or any harmful consequences if they refused to participate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Antibiotic Reaction, Antibiotic Side Effect, Antibiotic Resistant Infection, Antibiotic Resistant Strain, Infection, Bacterial, Infection, Laboratory
Keywords
Molar, Third; Moxifloxacin; Cefixime; Placebo, Postoperative Complications; Antibiotic Prophylaxis, Drug Resistance; Microbial Sensitivity Tests

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A RANDOMIZED CONTROLLED TRIAL
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients were randomly and equally assigned to treatment groups. The study was planned as a double-blind. Thus, neither the patients nor the researchers knew whether the patients were prescribed antibiotics or placebo tablets, because the tablets were marked with a label that was in the formed codebook. All the film-coated tablets used were of the same appearance (both the antibiotics and the placebo). There was 157 participants, patients and the same oral surgeon.
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: The first tested group
Arm Type
Active Comparator
Arm Description
Patients orally received film-coated tablets with either 400 mg of moxifloxacin. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.
Arm Title
Active Comparator: The second tested group
Arm Type
Active Comparator
Arm Description
Patients orally received film-coated tablets with either 400 mg of cefixime. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.
Arm Title
Placebo Comparator: The control group
Arm Type
Placebo Comparator
Arm Description
One third of patients received placebo-tablets containing indifferent substances with no antimicrobial action (99% microcrystalline cellulose, 0.5% silicon dioxide and 0.5% magnesium stearate, which were of the same colour and overall appearance as the used antibiotics. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 400 mg Oral Tablet
Other Intervention Name(s)
perioperative/prophylaxis
Intervention Description
All used film-coated tablets (400 mg moxifloxacin) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
Intervention Type
Drug
Intervention Name(s)
Cefixime 400 mg Oral Tablet
Other Intervention Name(s)
perioperative/prophylaxis
Intervention Description
All used film-coated tablets (400 mg cefixime) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
All used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
Primary Outcome Measure Information:
Title
Rate of postoperative infection at the surgical site (SSI)
Description
Signs of postoperative infection were registered clinically, based on the presence of local signs of inflammation and general signs of intoxication (elevated body temperature, accelerated erythrocyte sedimentation, leucocytosis, the level of C-reactive protein, etc. ).
Time Frame
Up to 12 weeks (3 months) after surgery.
Secondary Outcome Measure Information:
Title
Dry socket (alveolar osteitis)
Description
The dry socket (alveolar osteitis) was diagnosed based on reported severe pain in the wound area, accompanied by specific local clinical appearance of the operative wound and absence of pus.
Time Frame
Through 7 days.
Title
Postoperative pain assessed by visual analogue scale (VAS)
Description
The postoperative pain was assessed using a visual analogue scale (VAS). VAS represents a horizontally drawn length of 100 mm, the beginning of which indicates a pain-free state on the left side, and the end on the right side the state of the strongest pain imaginable. All patients, by placing a dash on the scale, indicated the intensity of pain that, on the appropriate day in the postoperative period, they felt in its strongest intensity. The intensity of pain was determined by measuring the distance of the marked place on the scale from the beginning of the scale on the left side and expressed in millimeters.
Time Frame
1st, 2nd day and 7th day after surgery.
Title
Postoperative swelling (oedema)
Description
The postoperative swelling (oedema) coefficient was obtained by measuring the preoperative and postoperative distance between specific reference points in millimetres. The reference points were: the outer corner of the eye and the angle of the lower jaw; lip corner and tragus; and chin tip and tragus.
Time Frame
1st, 2nd day and 7th day after surgery.
Title
Postoperative trismus (maximum inter-incisal opening of mouth)
Description
The degree of postoperative trismus was assessed by measuring the distance between mesio-incisal angles of the upper and lower central incisors at the maximum mouth opening ability.
Time Frame
1st, 2nd day and 7th day after surgery.
Title
Postoperative pain assessed by verbal rating scale (VRS)
Description
The postoperative pain was assessed using a verbal rating scale (VRS). VRS involves a numerical assessment of pain intensity based on six degrees (1-6) - no pain, barely sensitive pain, mild pain, moderate pain, severe pain and very strong, almost unbearable pain.
Time Frame
1st to 7th day after surgery.
Title
Postoperative pain assessed by number of analgesics
Description
In each patient, the moment of postoperative pain, its intensity at the indicated observation times was registered, and the need for additional analgesics was registered (patients recorded the number of analgesics consumed daily from the completed surgical intervention to suture removal in the postoperative pain monitoring protocol).
Time Frame
1st to 7th day after surgery.
Other Pre-specified Outcome Measures:
Title
Rate of antibiotic susceptibility and resistance of isolated microorganisms in vitro (microbiological assessment).
Description
The sensitivity of isolated microorganisms to moxifloxacin, cefixime and other antibiotics commonly prescribed in oral and maxillofacial surgery was tested microbiologically. Regarding the susceptibility to antimicrobial drugs, bacteria were classified according to the growth inhibition zone, into three categories: susceptible (S), intermediate (I) and resistant (R).
Time Frame
Up to 12 weeks (3 months) after surgery.
Title
Incidence of adverse drug events (ADEs) in the clinical trial
Description
During the study, any adverse event to drugs used in the clinical study will be recorded in accordance with the GCP.
Time Frame
Up to 24 days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients ≥18 years, indicated for surgical removal of the impacted mandibular third molars, with good systemic health (patients classified as ASA I and ASA II) were included in the study. Exclusion Criteria: hypersensitivity to study drugs; history of systemic antibacterial therapy within 6 months prior to randomization; pregnancy or breastfeeding; fluoroquinolone-related tendon disorder; clinically relevant cardiac conditions or QT interval prolonging drugs; severe hepatic insufficiency (Child-Pugh C). Also, criteria for not including the patients in the study were cases where, in addition to removing the impacted mandibular third molar, some other oral surgical procedure was performed, as well as patients with currently present pericoronitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Branislav V Bajkin, MD, DMD, PhD
Organizational Affiliation
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Branimir D Stošić, DMD, PhD
Organizational Affiliation
University of Novi Sad, Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26561441
Citation
Carter K, Worthington S. Predictors of Third Molar Impaction: A Systematic Review and Meta-analysis. J Dent Res. 2016 Mar;95(3):267-76. doi: 10.1177/0022034515615857. Epub 2015 Nov 11.
Results Reference
result
PubMed Identifier
18088870
Citation
Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
Results Reference
result
PubMed Identifier
17719384
Citation
Chuang SK, Perrott DH, Susarla SM, Dodson TB. Age as a risk factor for third molar surgery complications. J Oral Maxillofac Surg. 2007 Sep;65(9):1685-92. doi: 10.1016/j.joms.2007.04.019.
Results Reference
result
PubMed Identifier
24370576
Citation
Azenha MR, Kato RB, Bueno RB, Neto PJ, Ribeiro MC. Accidents and complications associated to third molar surgeries performed by dentistry students. Oral Maxillofac Surg. 2014 Dec;18(4):459-64. doi: 10.1007/s10006-013-0439-9. Epub 2013 Dec 27.
Results Reference
result
PubMed Identifier
17052624
Citation
Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.
Results Reference
result
PubMed Identifier
31027098
Citation
Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
Results Reference
result
PubMed Identifier
16876044
Citation
Kim JC, Choi SS, Wang SJ, Kim SG. Minor complications after mandibular third molar surgery: type, incidence, and possible prevention. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):e4-11. doi: 10.1016/j.tripleo.2005.10.050. Epub 2006 Jun 27.
Results Reference
result
PubMed Identifier
10625102
Citation
Monaco G, Staffolani C, Gatto MR, Checchi L. Antibiotic therapy in impacted third molar surgery. Eur J Oral Sci. 1999 Dec;107(6):437-41. doi: 10.1046/j.0909-8836.1999.eos107604.x.
Results Reference
result
PubMed Identifier
19531419
Citation
Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12.066.
Results Reference
result
PubMed Identifier
15510357
Citation
Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.
Results Reference
result
PubMed Identifier
11883966
Citation
Yuasa H, Kawai T, Sugiura M. Classification of surgical difficulty in extracting impacted third molars. Br J Oral Maxillofac Surg. 2002 Feb;40(1):26-31. doi: 10.1054/bjom.2001.0684.
Results Reference
result
PubMed Identifier
12190139
Citation
Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
Results Reference
result
PubMed Identifier
22338284
Citation
Bowe DC, Rogers S, Stassen LF. The management of dry socket/alveolar osteitis. J Ir Dent Assoc. 2011 Dec-2012 Jan;57(6):305-10.
Results Reference
result
PubMed Identifier
26116842
Citation
Taberner-Vallverdu M, Nazir M, Sanchez-Garces MA, Gay-Escoda C. Efficacy of different methods used for dry socket management: A systematic review. Med Oral Patol Oral Cir Bucal. 2015 Sep 1;20(5):e633-9. doi: 10.4317/medoral.20589.
Results Reference
result
PubMed Identifier
29053647
Citation
Taberner-Vallverdu M, Sanchez-Garces MA, Gay-Escoda C. Efficacy of different methods used for dry socket prevention and risk factor analysis: A systematic review. Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):e750-e758. doi: 10.4317/medoral.21705.
Results Reference
result
PubMed Identifier
20652078
Citation
Kolokythas A, Olech E, Miloro M. Alveolar osteitis: a comprehensive review of concepts and controversies. Int J Dent. 2010;2010:249073. doi: 10.1155/2010/249073. Epub 2010 Jun 24.
Results Reference
result
PubMed Identifier
23235637
Citation
Daly B, Sharif MO, Newton T, Jones K, Worthington HV. Local interventions for the management of alveolar osteitis (dry socket). Cochrane Database Syst Rev. 2012 Dec 12;12:CD006968. doi: 10.1002/14651858.CD006968.pub2.
Results Reference
result
PubMed Identifier
23390473
Citation
Bortoluzzi MC, Capella DL, Barbieri T, Pagliarini M, Cavalieri T, Manfro R. A single dose of amoxicillin and dexamethasone for prevention of postoperative complications in third molar surgery: a randomized, double-blind, placebo controlled clinical trial. J Clin Med Res. 2013 Feb;5(1):26-33. doi: 10.4021/jocmr1160w. Epub 2013 Jan 11.
Results Reference
result
PubMed Identifier
17884515
Citation
Ren YF, Malmstrom HS. Effectiveness of antibiotic prophylaxis in third molar surgery: a meta-analysis of randomized controlled clinical trials. J Oral Maxillofac Surg. 2007 Oct;65(10):1909-21. doi: 10.1016/j.joms.2007.03.004.
Results Reference
result
PubMed Identifier
15088029
Citation
Benediktsdottir IS, Wenzel A, Petersen JK, Hintze H. Mandibular third molar removal: risk indicators for extended operation time, postoperative pain, and complications. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Apr;97(4):438-46. doi: 10.1016/j.tripleo.2003.10.018.
Results Reference
result
PubMed Identifier
17484797
Citation
Blondeau F, Daniel NG. Extraction of impacted mandibular third molars: postoperative complications and their risk factors. J Can Dent Assoc. 2007 May;73(4):325.
Results Reference
result
PubMed Identifier
23152221
Citation
Lodi G, Figini L, Sardella A, Carrassi A, Del Fabbro M, Furness S. Antibiotics to prevent complications following tooth extractions. Cochrane Database Syst Rev. 2012 Nov 14;11:CD003811. doi: 10.1002/14651858.CD003811.pub2.
Results Reference
result
PubMed Identifier
17666691
Citation
Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
Results Reference
result
PubMed Identifier
16648771
Citation
Salmeron-Escobar JI, del Amo-Fernandez de Velasco A. Antibiotic prophylaxis in Oral and Maxillofacial Surgery. Med Oral Patol Oral Cir Bucal. 2006 May 1;11(3):E292-6.
Results Reference
result
PubMed Identifier
25279397
Citation
Rodrigues WC, Okamoto R, Pellizzer EP, dos Carrijo AC, de Almeida RS, de Melo WM. Antibiotic prophylaxis for third molar extraction in healthy patients: Current scientific evidence. Quintessence Int. 2015 Feb;46(2):149-61. doi: 10.3290/j.qi.a32825.
Results Reference
result
PubMed Identifier
27060492
Citation
Moreno-Drada JA, Garcia-Perdomo HA. Effectiveness of Antimicrobial Prophylaxis in Preventing the Spread of Infection as a Result of Oral Procedures: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2016 Jul;74(7):1313-21. doi: 10.1016/j.joms.2016.03.006. Epub 2016 Mar 15.
Results Reference
result
PubMed Identifier
19753908
Citation
Moloney J, Stassen LF. Pericoronitis: treatment and a clinical dilemma. J Ir Dent Assoc. 2009 Aug-Sep;55(4):190-2.
Results Reference
result
PubMed Identifier
31480662
Citation
Wehr C, Cruz G, Young S, Fakhouri WD. An Insight into Acute Pericoronitis and the Need for an Evidence-Based Standard of Care. Dent J (Basel). 2019 Sep 2;7(3):88. doi: 10.3390/dj7030088.
Results Reference
result
PubMed Identifier
23489756
Citation
Davies SC, Fowler T, Watson J, Livermore DM, Walker D. Annual Report of the Chief Medical Officer: infection and the rise of antimicrobial resistance. Lancet. 2013 May 11;381(9878):1606-9. doi: 10.1016/S0140-6736(13)60604-2. Epub 2013 Mar 12. No abstract available.
Results Reference
result
PubMed Identifier
25436105
Citation
Llor C, Bjerrum L. Antimicrobial resistance: risk associated with antibiotic overuse and initiatives to reduce the problem. Ther Adv Drug Saf. 2014 Dec;5(6):229-41. doi: 10.1177/2042098614554919.
Results Reference
result
PubMed Identifier
26857041
Citation
Marra F, George D, Chong M, Sutherland S, Patrick DM. Antibiotic prescribing by dentists has increased: Why? J Am Dent Assoc. 2016 May;147(5):320-7. doi: 10.1016/j.adaj.2015.12.014. Epub 2016 Feb 5.
Results Reference
result
PubMed Identifier
28126225
Citation
Roberts RM, Bartoces M, Thompson SE, Hicks LA. Antibiotic prescribing by general dentists in the United States, 2013. J Am Dent Assoc. 2017 Mar;148(3):172-178.e1. doi: 10.1016/j.adaj.2016.11.020. Epub 2017 Jan 23.
Results Reference
result
PubMed Identifier
10870281
Citation
Palmer NA, Pealing R, Ireland RS, Martin MV. A study of therapeutic antibiotic prescribing in National Health Service general dental practice in England. Br Dent J. 2000 May 27;188(10):554-8. doi: 10.1038/sj.bdj.4800538.
Results Reference
result
PubMed Identifier
24559212
Citation
Loffler C, Bohmer F, Hornung A, Lang H, Burmeister U, Podbielski A, Wollny A, Kundt G, Altiner A. Dental care resistance prevention and antibiotic prescribing modification-the cluster-randomised controlled DREAM trial. Implement Sci. 2014 Feb 22;9:27. doi: 10.1186/1748-5908-9-27.
Results Reference
result
PubMed Identifier
29136646
Citation
Loffler C, Bohmer F. The effect of interventions aiming to optimise the prescription of antibiotics in dental care-A systematic review. PLoS One. 2017 Nov 14;12(11):e0188061. doi: 10.1371/journal.pone.0188061. eCollection 2017.
Results Reference
result
PubMed Identifier
18167394
Citation
Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. J Am Dent Assoc. 2008 Jan;139 Suppl:3S-24S. doi: 10.14219/jada.archive.2008.0346. Erratum In: J Am Dent Assoc. 2008 Mar;139(3):253.
Results Reference
result
PubMed Identifier
25467569
Citation
Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.
Results Reference
result
PubMed Identifier
18390528
Citation
Richey R, Wray D, Stokes T; Guideline Development Group. Prophylaxis against infective endocarditis: summary of NICE guidance. BMJ. 2008 Apr 5;336(7647):770-1. doi: 10.1136/bmj.39510.423148.AD. No abstract available.
Results Reference
result
PubMed Identifier
16940094
Citation
Diz Dios P, Tomas Carmona I, Limeres Posse J, Medina Henriquez J, Fernandez Feijoo J, Alvarez Fernandez M. Comparative efficacies of amoxicillin, clindamycin, and moxifloxacin in prevention of bacteremia following dental extractions. Antimicrob Agents Chemother. 2006 Sep;50(9):2996-3002. doi: 10.1128/AAC.01550-05.
Results Reference
result
PubMed Identifier
19138601
Citation
Limeres J, Sanroman JF, Tomas I, Diz P. Patients' perception of recovery after third molar surgery following postoperative treatment with moxifloxacin versus amoxicillin and clavulanic acid: a randomized, double-blind, controlled study. J Oral Maxillofac Surg. 2009 Feb;67(2):286-91. doi: 10.1016/j.joms.2008.06.061.
Results Reference
result
PubMed Identifier
31052566
Citation
Cervino G, Cicciu M, Biondi A, Bocchieri S, Herford AS, Laino L, Fiorillo L. Antibiotic Prophylaxis on Third Molar Extraction: Systematic Review of Recent Data. Antibiotics (Basel). 2019 May 2;8(2):53. doi: 10.3390/antibiotics8020053.
Results Reference
result
PubMed Identifier
28865815
Citation
Sidana S, Mistry Y, Gandevivala A, Motwani N. Evaluation of the Need for Antibiotic Prophylaxis During Routine Intra-alveolar Dental Extractions in Healthy Patients: A Randomized Double-Blind Controlled Trial. J Evid Based Dent Pract. 2017 Sep;17(3):184-189. doi: 10.1016/j.jebdp.2017.04.007. Epub 2017 Apr 27.
Results Reference
result
PubMed Identifier
27298545
Citation
Prajapati A, Prajapati A, Sathaye S. Benefits of not Prescribing Prophylactic Antibiotics After Third Molar Surgery. J Maxillofac Oral Surg. 2016 Jun;15(2):217-20. doi: 10.1007/s12663-015-0814-1. Epub 2015 Jul 5.
Results Reference
result
PubMed Identifier
17408924
Citation
Kaczmarzyk T, Wichlinski J, Stypulkowska J, Zaleska M, Panas M, Woron J. Single-dose and multi-dose clindamycin therapy fails to demonstrate efficacy in preventing infectious and inflammatory complications in third molar surgery. Int J Oral Maxillofac Surg. 2007 May;36(5):417-22. doi: 10.1016/j.ijom.2006.12.003. Epub 2007 Apr 3.
Results Reference
result
PubMed Identifier
26706491
Citation
Marcussen KB, Laulund AS, Jorgensen HL, Pinholt EM. A Systematic Review on Effect of Single-Dose Preoperative Antibiotics at Surgical Osteotomy Extraction of Lower Third Molars. J Oral Maxillofac Surg. 2016 Apr;74(4):693-703. doi: 10.1016/j.joms.2015.11.017. Epub 2015 Nov 23.
Results Reference
result
PubMed Identifier
21470751
Citation
Lopez-Cedrun JL, Pijoan JI, Fernandez S, Santamaria J, Hernandez G. Efficacy of amoxicillin treatment in preventing postoperative complications in patients undergoing third molar surgery: a prospective, randomized, double-blind controlled study. J Oral Maxillofac Surg. 2011 Jun;69(6):e5-14. doi: 10.1016/j.joms.2011.01.019. Epub 2011 Apr 5.
Results Reference
result
PubMed Identifier
17236918
Citation
Halpern LR, Dodson TB. Does prophylactic administration of systemic antibiotics prevent postoperative inflammatory complications after third molar surgery? J Oral Maxillofac Surg. 2007 Feb;65(2):177-85. doi: 10.1016/j.joms.2006.10.016.
Results Reference
result
PubMed Identifier
15953905
Citation
Arteagoitia I, Diez A, Barbier L, Santamaria G, Santamaria J. Efficacy of amoxicillin/clavulanic acid in preventing infectious and inflammatory complications following impacted mandibular third molar extraction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jul;100(1):e11-8. doi: 10.1016/j.tripleo.2005.03.025.
Results Reference
result
PubMed Identifier
30145064
Citation
Menon RK, Gopinath D, Li KY, Leung YY, Botelho MG. Does the use of amoxicillin/amoxicillin-clavulanic acid in third molar surgery reduce the risk of postoperative infection? A systematic review with meta-analysis. Int J Oral Maxillofac Surg. 2019 Feb;48(2):263-273. doi: 10.1016/j.ijom.2018.08.002. Epub 2018 Aug 23.
Results Reference
result
PubMed Identifier
31803393
Citation
Pham TDM, Ziora ZM, Blaskovich MAT. Quinolone antibiotics. Medchemcomm. 2019 Jun 28;10(10):1719-1739. doi: 10.1039/c9md00120d. eCollection 2019 Oct 1.
Results Reference
result
PubMed Identifier
26493435
Citation
Ardila CM, Guzman IC. Clinical Factors Influencing the Efficacy of Systemic Moxifloxacin in the Therapy of Patients With Generalized Aggressive Periodontitis: A Multilevel Analysis From a Clinical Trial. Glob J Health Sci. 2015 Jun 25;8(3):80-8. doi: 10.5539/gjhs.v8n3p80.
Results Reference
result
PubMed Identifier
22354306
Citation
Sobottka I, Wegscheider K, Balzer L, Boger RH, Hallier O, Giersdorf I, Streichert T, Haddad M, Platzer U, Cachovan G. Microbiological analysis of a prospective, randomized, double-blind trial comparing moxifloxacin and clindamycin in the treatment of odontogenic infiltrates and abscesses. Antimicrob Agents Chemother. 2012 May;56(5):2565-9. doi: 10.1128/AAC.06428-11. Epub 2012 Feb 21.
Results Reference
result
PubMed Identifier
26162260
Citation
Shrivastava R, Rai VK, Kumar A, Sinha S, Tripathi P, Gupta K, Sabharwal S. An in vitro Comparison of Endodontic Medicaments Propolis and Calcium Hydroxide alone and in Combination with Ciprofloxacin and Moxifloxacin against Enterococcus Faecalis. J Contemp Dent Pract. 2015 May 1;16(5):394-9. doi: 10.5005/jp-journals-10024-1696.
Results Reference
result
PubMed Identifier
9925551
Citation
Jones ME, Visser MR, Klootwijk M, Heisig P, Verhoef J, Schmitz FJ. Comparative activities of clinafloxacin, grepafloxacin, levofloxacin, moxifloxacin, ofloxacin, sparfloxacin, and trovafloxacin and nonquinolones linozelid, quinupristin-dalfopristin, gentamicin, and vancomycin against clinical isolates of ciprofloxacin-resistant and -susceptible Staphylococcus aureus strains. Antimicrob Agents Chemother. 1999 Feb;43(2):421-3. doi: 10.1128/AAC.43.2.421.
Results Reference
result
PubMed Identifier
16518713
Citation
Dalhoff A. Immunomodulatory activities of fluoroquinolones. Infection. 2005 Dec;33 Suppl 2:55-70. doi: 10.1007/s15010-005-8209-8.
Results Reference
result
PubMed Identifier
12781508
Citation
Dalhoff A, Shalit I. Immunomodulatory effects of quinolones. Lancet Infect Dis. 2003 Jun;3(6):359-71. doi: 10.1016/s1473-3099(03)00658-3.
Results Reference
result
PubMed Identifier
28341449
Citation
Lang MS, Gonzalez ML, Dodson TB. Do Antibiotics Decrease the Risk of Inflammatory Complications After Third Molar Removal in Community Practices? J Oral Maxillofac Surg. 2017 Feb;75(2):249-255. doi: 10.1016/j.joms.2016.09.044. Epub 2016 Oct 6.
Results Reference
result
PubMed Identifier
32507863
Citation
Ardila CM, Florez-Florez J, Castaneda-Parra LD, Guzman IC, Bedoya-Garcia JA. Moxifloxacin versus amoxicillin plus metronidazole as adjunctive therapy for generalized aggressive periodontitis: a pilot randomized controlled clinical trial. Quintessence Int. 2020;51(8):612-621. doi: 10.3290/j.qi.a44715.
Results Reference
result
PubMed Identifier
23159124
Citation
Oomens MA, Forouzanfar T. Antibiotic prophylaxis in third molar surgery: a review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Dec;114(6):e5-12. doi: 10.1016/j.oooo.2011.10.023. Epub 2012 May 30.
Results Reference
result
PubMed Identifier
14699540
Citation
Poeschl PW, Eckel D, Poeschl E. Postoperative prophylactic antibiotic treatment in third molar surgery--a necessity? J Oral Maxillofac Surg. 2004 Jan;62(1):3-8; discussion 9. doi: 10.1016/j.joms.2003.05.004.
Results Reference
result
PubMed Identifier
18760616
Citation
Warnke PH, Becker ST, Springer IN, Haerle F, Ullmann U, Russo PA, Wiltfang J, Fickenscher H, Schubert S. Penicillin compared with other advanced broad spectrum antibiotics regarding antibacterial activity against oral pathogens isolated from odontogenic abscesses. J Craniomaxillofac Surg. 2008 Dec;36(8):462-7. doi: 10.1016/j.jcms.2008.07.001. Epub 2008 Aug 29.
Results Reference
result
PubMed Identifier
3320926
Citation
Tally FP, Desjardins RE, McCarthy EF, Cartwright K. Safety profile of cefixime. Pediatr Infect Dis J. 1987 Oct;6(10):976-80. doi: 10.1097/00006454-198710000-00037.
Results Reference
result
PubMed Identifier
28246379
Citation
Martens E, Demain AL. The antibiotic resistance crisis, with a focus on the United States. J Antibiot (Tokyo). 2017 May;70(5):520-526. doi: 10.1038/ja.2017.30. Epub 2017 Mar 1.
Results Reference
result
PubMed Identifier
17229548
Citation
Lacasa JM, Jimenez JA, Ferras V, Bossom M, Sola-Morales O, Garcia-Rey C, Aguilar L, Garau J. Prophylaxis versus pre-emptive treatment for infective and inflammatory complications of surgical third molar removal: a randomized, double-blind, placebo-controlled, clinical trial with sustained release amoxicillin/clavulanic acid (1000/62.5 mg). Int J Oral Maxillofac Surg. 2007 Apr;36(4):321-7. doi: 10.1016/j.ijom.2006.11.007. Epub 2007 Jan 16.
Results Reference
result
PubMed Identifier
31011962
Citation
Blumenthal KG, Lu N, Zhang Y, Walensky RP, Choi HK. Recorded Penicillin Allergy and Risk of Mortality: a Population-Based Matched Cohort Study. J Gen Intern Med. 2019 Sep;34(9):1685-1687. doi: 10.1007/s11606-019-04991-y. No abstract available.
Results Reference
result
PubMed Identifier
24842194
Citation
Redgrave LS, Sutton SB, Webber MA, Piddock LJ. Fluoroquinolone resistance: mechanisms, impact on bacteria, and role in evolutionary success. Trends Microbiol. 2014 Aug;22(8):438-45. doi: 10.1016/j.tim.2014.04.007. Epub 2014 May 16.
Results Reference
result
PubMed Identifier
31362351
Citation
Chaudhry SB, Veve MP, Wagner JL. Cephalosporins: A Focus on Side Chains and beta-Lactam Cross-Reactivity. Pharmacy (Basel). 2019 Jul 29;7(3):103. doi: 10.3390/pharmacy7030103.
Results Reference
result
PubMed Identifier
18663500
Citation
Al-Nawas B, Walter C, Morbach T, Seitner N, Siegel E, Maeurer M, Krummenauer F. Clinical and microbiological efficacy of moxifloxacin versus amoxicillin/clavulanic acid in severe odontogenic abscesses: a pilot study. Eur J Clin Microbiol Infect Dis. 2009 Jan;28(1):75-82. doi: 10.1007/s10096-008-0587-2. Epub 2008 Jul 29.
Results Reference
result
PubMed Identifier
31144548
Citation
Nymoen Aasbrenn M, Skeie I, Berild D. Compliance to antibiotic guidelines leads to more appropriate use of antibiotics in skin and soft tissue infections in injecting drug users. Infect Dis (Lond). 2019 Aug;51(8):570-577. doi: 10.1080/23744235.2019.1617435. Epub 2019 May 30.
Results Reference
result
PubMed Identifier
20346713
Citation
Poeschl PW, Spusta L, Russmueller G, Seemann R, Hirschl A, Poeschl E, Klug C, Ewers R. Antibiotic susceptibility and resistance of the odontogenic microbiological spectrum and its clinical impact on severe deep space head and neck infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Aug;110(2):151-6. doi: 10.1016/j.tripleo.2009.12.039. Epub 2010 Mar 25.
Results Reference
result
PubMed Identifier
26946211
Citation
Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
Results Reference
result
PubMed Identifier
26644841
Citation
Gomez-Arambula H, Hidalgo-Hurtado A, Rodriguez-Flores R, Gonzalez-Amaro AM, Garrocho-Rangel A, Pozos-Guillen A. Moxifloxacin versus Clindamycin/Ceftriaxone in the management of odontogenic maxillofacial infectious processes: A preliminary, intrahospital, controlled clinical trial. J Clin Exp Dent. 2015 Dec 1;7(5):e634-9. doi: 10.4317/jced.52627. eCollection 2015 Dec.
Results Reference
result
PubMed Identifier
21712864
Citation
Daabiss M. American Society of Anaesthesiologists physical status classification. Indian J Anaesth. 2011 Mar;55(2):111-5. doi: 10.4103/0019-5049.79879.
Results Reference
result
Links:
URL
http://www.doiserbia.nb.rs/Article.aspx?id=0042-84502000122S#.YPhwrtUzaM8
Description
A comparative analysis of the efficacy of moxifloxacin and cefixime in reduction postoperative inflammatory sequelae after mandibular third molar surgery

Learn more about this trial

Complications After Lower Third Molar Surgery

We'll reach out to this number within 24 hrs