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Complications After Lower Third Molar Surgery

Primary Purpose

Postoperative Complications, Third Molar

Status
Completed
Phase
Phase 1
Locations
Croatia
Study Type
Interventional
Intervention
Lower third molar surgery
Amoxicillin 500 Mg
Placebo
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring third molar, oral surgical procedures, antibiotic prophylaxis, placebo effect

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal

Exclusion Criteria:

  • The exclusion criteria in this study were systematic diseases, with developing local infections, current smokers, pregnant women, lactating females, patients using oral contraceptive drugs and those under any antibiotic coverage.

Sites / Locations

  • School of dental medicine, University of Zagreb

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

The first tested subgroup

The first control subgroup

The second tested subgroup

The second control subgroup

Arm Description

The tested subgroup from the main group without prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery.

The control subgroup from the main group without prior inflammation received a placebo one hour prior the lower third molar surgery .

The tested subgroup from the main group with prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery .

The control subgroup from the main group with prior inflammation received a placebo one hour prior the lower third molar surgery .

Outcomes

Primary Outcome Measures

Pain
Patients evaluated their postoperative pain with grades from 0-10 using according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain"(10).

Secondary Outcome Measures

Swelling
The post-operative swelling was assessed on postoperative days 1 and 7, using four-point scale as 0=no swelling, 1=mild swelling, 2=moderate swelling, 3=severe swelling.
Wound healing ( AO, SSI )
Surgeon evaluated the type of post-extraction alveolus healing as following normal healing, acute inflammation followed by infected alveolus and dry socket.
Maximum inter-incisal opening of mouth
The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using digital calliper (Caliper-Digital; Salvin Dental Specialties, Inc, Charlotte, NC).
Increased body temperature
Increased body temperature was measured by patient at home during postoperative period of seven days. Body temperature within 36.0ºC and 37.5ºC was evaluated as normal. The body temperature under 37.5 ºC was evaluated as increased. All temperatures were measured at the same time of the day, between 9:00 and 11:00 a.m.
Hemorrhage
Hemorrhage was observed by patient during next seven days after the surgical procedure. It was classified as absent or present through following days. Present hemorrhage was classified as light or intense.

Full Information

First Posted
April 17, 2017
Last Updated
June 14, 2017
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT03130933
Brief Title
Complications After Lower Third Molar Surgery
Official Title
Does a Single Dose of Systemic Antibiotics Prevent Postoperative Inflammatory Complications After Lower Third Molar Surgery? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: The objective of the study was to evaluate the effectiveness of a prophylactic single preoperative dose of amoxicillin in decreasing complications after lower third molar surgery. Materials and methods: The sample consisted of 400 patients randomly divided in two groups consisting of 200 patients per each group. The patients underwent third molar surgery at the Department of Oral Surgery, Clinical Hospital Dubrava, Croatia, in the period between April 2010. and November 2016. Unlike the patients from the second group, the first group of patients had never been diagnosed inflammation prior the surgical procedure. The main tested groups were further divided in two subgroups (control and tested): the tested subgroup (100 patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure, while the second control subgroup (100 patients) received a placebo. Complications, including swelling, alveolar osteitis (AO), infection at the surgical site (SSI), limited mouth opening, pain, bleeding, and increased body temperature, were evaluated postoperatively. Evaluation was done on the first postoperative day and 7 days after surgery.
Detailed Description
Study design and sample description This prospective study was performed at the Department of Oral Surgery of Clinical Hospital Dubrava, Zagreb, Croatia, in the period from April 2010. through November 2016. All patients voluntarily agreed and written consent to participate in the study was obtained from each participant. The study was approved by Ethics Committee of the School of Dental Medicine, Zagreb, Croatia (81-2009). The identity of the subjects was protected in all phases of the study. The exclusion criteria in this study were systematic diseases, with developing local infections, current smokers, pregnant women, lactating females, patients using oral contraceptive drugs and those under any antibiotic coverage. The sample consisted of systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal randomly divided into two main groups of patients. Unlike the patients from the second group, the first group of patients had never been diagnosed inflammation prior the surgical procedure. The main tested groups were further divided in two subgroups (control and tested): the tested subgroup (100 patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure, while the second control subgroup (100 patients) received a placebo. The selection of third molars for control and study subgroup was made according to Pederson difficulty index (9). According to this index (Table 1), the patients are classified into 3 groups: easy, moderate and difficult. The patients from this study who were classified into a difficult group were excluded from the study due to a longer and complicated surgical procedure with an expected prolonged recovery period and possible postoperative complications. The patients were recalled for follow-up on post-operative days one and seven. In all tested groups data had been obtained by using identical questionnaire. The following symptoms were assessed: pain, swelling, wound healing (AO, SSI), maximum inter-incisal opening of mouth, increased body temperature and hemorrhage. A postoperative follow-up was done always by the single experienced therapist. Patients evaluated their postoperative pain with grades from 0-10 using according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain" (10). Surgeon evaluated the type of post-extraction alveolus healing as following normal healing, acute inflammation followed by infected alveolus and dry socket. The surgeon who assessed wound swelling did not know to which group the patient was allocated. The method of assessing the swelling was described in our previous study (10). The post-operative swelling was assessed on postoperative days 1 and 7, using four-point scale as 0=no swelling, 1=mild swelling, 2=moderate swelling, 3=severe swelling. The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using digital calliper (Caliper-Digital; Salvin Dental Specialties, Inc, Charlotte, NC). Increased body temperature was measured by patient at home during postoperative period of seven days. Body temperature within 36.0ºC and 37.5ºC was evaluated as normal. The body temperature under 37.5 ºC was evaluated as increased. All temperatures were measured at the same time of the day, between 9:00 and 11:00 a.m. Hemorrhage was observed by patient during next seven days after the surgical procedure. It was classified as absent or present through following days. Present hemorrhage was classified as light or intense. The outcome variable was the presence or absence of an inflammatory complication after third molar surgery (SSI or AO). A diagnosis of SSI was identified by purulent discharge from the surgical site at any point postoperatively, fever, lymphadenopathy, or pain and edema warranting surgical intervention and/or systematic antibiotics. Alveolar osteitis was diagnosed in cases of an empty alveolar socket, increasing pain lasting more than 2 days after surgery, and exposed alveolar bone tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Third Molar
Keywords
third molar, oral surgical procedures, antibiotic prophylaxis, placebo effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A RANDOMIZED CONTROLLED TRIAL
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
There was 400 participiants, patients and the same oral surgeon
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The first tested subgroup
Arm Type
Active Comparator
Arm Description
The tested subgroup from the main group without prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery.
Arm Title
The first control subgroup
Arm Type
Placebo Comparator
Arm Description
The control subgroup from the main group without prior inflammation received a placebo one hour prior the lower third molar surgery .
Arm Title
The second tested subgroup
Arm Type
Active Comparator
Arm Description
The tested subgroup from the main group with prior inflammation received a prophylactic single dose of 4 x Amoxicillin 500 Mg one hour prior the lower third molar surgery .
Arm Title
The second control subgroup
Arm Type
Placebo Comparator
Arm Description
The control subgroup from the main group with prior inflammation received a placebo one hour prior the lower third molar surgery .
Intervention Type
Procedure
Intervention Name(s)
Lower third molar surgery
Intervention Description
All surgical procedures were performed under local anaesthesia (alveolar nerve block) with 2% lidocaine chloride. The full-thickness mucoperiosteal flap was raised using buccal approach, adequate osteotomy was done using micromotor handpiece and bur, and third molar removal was finished using elevating instruments in the appropriate direction. Removal of bone dust, granulation tissue and broken tooth fragments were done in order to wound toileting. Gentle, sterile saline irrigation was done on the end. Primary closure of the surgical area was done using 3-0 silk sutures.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 500 Mg
Other Intervention Name(s)
prophylaxis
Intervention Description
The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.
Primary Outcome Measure Information:
Title
Pain
Description
Patients evaluated their postoperative pain with grades from 0-10 using according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain"(10).
Time Frame
1 day and 7 days after surgery
Secondary Outcome Measure Information:
Title
Swelling
Description
The post-operative swelling was assessed on postoperative days 1 and 7, using four-point scale as 0=no swelling, 1=mild swelling, 2=moderate swelling, 3=severe swelling.
Time Frame
1 day and 7 days after surgery
Title
Wound healing ( AO, SSI )
Description
Surgeon evaluated the type of post-extraction alveolus healing as following normal healing, acute inflammation followed by infected alveolus and dry socket.
Time Frame
1 day and 7 days after surgery
Title
Maximum inter-incisal opening of mouth
Description
The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using digital calliper (Caliper-Digital; Salvin Dental Specialties, Inc, Charlotte, NC).
Time Frame
1 day and 7 days after surgery
Title
Increased body temperature
Description
Increased body temperature was measured by patient at home during postoperative period of seven days. Body temperature within 36.0ºC and 37.5ºC was evaluated as normal. The body temperature under 37.5 ºC was evaluated as increased. All temperatures were measured at the same time of the day, between 9:00 and 11:00 a.m.
Time Frame
through 7 days
Title
Hemorrhage
Description
Hemorrhage was observed by patient during next seven days after the surgical procedure. It was classified as absent or present through following days. Present hemorrhage was classified as light or intense.
Time Frame
through 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: systematically healthy subjects between 18 to 40 years (both gender) and having semi-impacted lower third molars indicated for surgical removal Exclusion Criteria: The exclusion criteria in this study were systematic diseases, with developing local infections, current smokers, pregnant women, lactating females, patients using oral contraceptive drugs and those under any antibiotic coverage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Granić, DMD,PhD
Organizational Affiliation
Second author
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tihomir Kuna, DMD, PhD
Organizational Affiliation
Third author
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dinko Knežević, DMD
Organizational Affiliation
fourth author
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nino Grgić, DMD
Organizational Affiliation
fifth author
Official's Role
Study Chair
Facility Information:
Facility Name
School of dental medicine, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Links:
URL
http://docplayer.net/29390208-Pre-and-post-operative-antibiotic-prophylaxis-in-the-prevention-of-complications-following-third-molar-surgery.html#show_full_text
Description
Conaty S, Hoang H, Kirshen D, Kwong C, Schroeder E, Stromme A: Pre and post-operative antibiotic prophylaxis in the prevention of complications following third molars surgery

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Complications After Lower Third Molar Surgery

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