Systemic and Local Antimicrobials in the Management of Dental Abscess in Children
Primary Purpose
Dentoalveolar Abscess
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Odontopaste®
Pulpdent
Amoxicillin
Sponsored by
About this trial
This is an interventional treatment trial for Dentoalveolar Abscess focused on measuring Odontogenic Infections, Paediatric Patients, Local Antimicrobials, Systemic Antimicrobials, Dentoalveolar Abscess, Apical Dentoalveolar Abscess, Periapical Abscess, Suppurative Periapical Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with acute odontogenic infections on primary teeth with evidence of intra-oral / extra- oral swelling and pus discharge
- Absence of any systemic disease
- Age group between 3-11 years
- Malaysian citizen
Exclusion Criteria:
- Patients taking antibiotics 30 days prior to their attendance to the department
- Presence of any systemic disease
- Patients with cellulitis
- Patients suffering from spreading odontogenic infections which require hospitalization or immediate IV antibiotic treatment
- Tooth with poor prognosis for extraction
- Extensively resorbed roots (> 2/3rd)
- Patients allergic or resistance to amoxicillin
- Non-Malaysian citizen
Sites / Locations
- University of Malaya
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Intra-canal Odontopaste®
Intra-canal Pulpdent
Oral Amoxicillin
Arm Description
Single visit placement of Odontopaste®
Single visit placement of Pulpdent
Amoxicillin 15mg/kg tds for 5 days
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7
Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews.
Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7
Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews.
Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7
Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful.
Mean Change From Baseline in Temperature Score at Days 3, 5 or 7
Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)
Mean Change From Baseline in Trismus Score at Days 3, 5 or 7
Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm).
Mean Change From Baseline in Percussion Score at Days 3, 5 or 7
Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness.
Mean Change From Baseline in Fistula Score at Days 3, 5 or 7
Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula
Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7
Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge.
Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7
Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment.
Mean change of ECOHIS scores from baseline and at Day 5 or Day 7
Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = "I don't know". The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7.
Secondary Outcome Measures
Quantification of Individual Target Species
A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03761264
Brief Title
Systemic and Local Antimicrobials in the Management of Dental Abscess in Children
Official Title
Clinical, Microbiological and Quality of Life Outcomes Following Use of Systemic and Local Antimicrobials in the Management of Odontogenic Infections in Paediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dental infections originating in the teeth are routinely managed systemically with a course of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental infections can also be managed by removing the offending cause of the infection followed by placement of an intra-canal medication which acts as a local antimicrobial. Intra-canal medicaments are being used in clinical practice following root canal treatment. The investigators hypothesize that the effect of intra-canal antimicrobials in the management of dental infections will be the better than oral antibiotics in terms of clinical , microbial and oral- health quality of life parameters. This will be a three-arm, parallel, comparative, randomized study with the aim of assessing the efficacy of intra-canal medication and oral antibiotics in reducing the infection and treatment of odontogenic infections, based on signs and symptoms and microbial count. The study will be performed in child participants between the age group of 3 to 11 years presenting with acute odontogenic infections. Participants will be randomized by block randomization. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the response. Participants will be assessed on Day 3 and Day 5/7. Concurrently, the oral health-related quality of life (OHRQoL) following these clinical interventions in children will be recorded and again on Day 14. Quantitative assessment of microorganisms seen in the root canals and the changes seen in the microbial flora through the treatment will help us to determine the best antimicrobial agent to be used in the management of odontogenic infections.
Detailed Description
This study will comprise of a three-arm, parallel, comparative, randomized treatment of children aged 3 to 11 years presenting with acute odontogenic infection. The three arms of the study includes 1) Odontopaste® as a one time intra-canal placement, 2) Calcium hydroxide (gold standard) as a one time intra-canal placement and 3) a course of amoxicillin three times daily for 5 days administered orally with meal. Patients will not receive additional medical therapy such as analgesics or anti-inflammatory drugs. The participants will be selected for the treatment based on a block randomization in groups of three. On Day 1 after confirming the eligibility based on clinical examination and radiographic finding, informed consent will be obtained. At baseline (Day 1), clinical parameters including pain,swelling, regional lymphadenitis, percussion of the tooth, trismus, fistula and pus discharge will be recorded. Participant will undergo an intervention whereby the tooth will be opened from the clinical crown followed by microbiological sampling, drainage and irrigation of the tooth, intra-canal medicament placed in the canals according to randomization and the cavity sealed with a Glass ionomer cement. Participants in the oral antibiotic group will have no intra-canal medicament placed and instead a sterile cotton pellet placed. Simultaneously, the Malay-ECOHIS will be given to the parent/guardian of the participant. The microbiological sampling will be stored in an appropriate transport medium and sent to the central laboratory for quantitative assessment via quantitative polymerase chain reaction (qPCR) using SYBR® Green. Participants will be assessed on Day 3 for clinical parameters and the integrity of restoration. The next and final assessment will be done at Day 5/7, where clinical parameters will be recorded along with microbiological sampling as in Day 1. The Malay-ECOHIS survey will be repeated. The primary objective of the study is to assess the resolution of the infection based on 1) clinical parameters, 2) microbiological sampling and 3) oral health quality of life. The treatment will be carried out by five operators who are calibrated and the individual sub components such as recording clinical parameters, microbiological sampling and assessing the OHRQoL questionnaire will be carried out by the same operator respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentoalveolar Abscess
Keywords
Odontogenic Infections, Paediatric Patients, Local Antimicrobials, Systemic Antimicrobials, Dentoalveolar Abscess, Apical Dentoalveolar Abscess, Periapical Abscess, Suppurative Periapical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-canal Odontopaste®
Arm Type
Experimental
Arm Description
Single visit placement of Odontopaste®
Arm Title
Intra-canal Pulpdent
Arm Type
Active Comparator
Arm Description
Single visit placement of Pulpdent
Arm Title
Oral Amoxicillin
Arm Type
Active Comparator
Arm Description
Amoxicillin 15mg/kg tds for 5 days
Intervention Type
Drug
Intervention Name(s)
Odontopaste®
Other Intervention Name(s)
Zinc Oxide based endodontic dressing
Intervention Description
Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste® will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
Intervention Type
Drug
Intervention Name(s)
Pulpdent
Other Intervention Name(s)
Calcium hydroxide endodontic paste
Intervention Description
Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxycillin
Intervention Description
Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7
Description
Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews.
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7
Description
Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews.
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7
Description
Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful.
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Temperature Score at Days 3, 5 or 7
Description
Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Trismus Score at Days 3, 5 or 7
Description
Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm).
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Percussion Score at Days 3, 5 or 7
Description
Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness.
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Fistula Score at Days 3, 5 or 7
Description
Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7
Description
Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge.
Time Frame
Baseline, Days 3, 5 or 7
Title
Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7
Description
Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment.
Time Frame
Baseline, Day 5 or Day 7
Title
Mean change of ECOHIS scores from baseline and at Day 5 or Day 7
Description
Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = "I don't know". The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7.
Time Frame
Baseline, Day 5 or Day 7
Secondary Outcome Measure Information:
Title
Quantification of Individual Target Species
Description
A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species.
Time Frame
First 2 Months of Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with acute odontogenic infections on primary teeth with evidence of intra-oral / extra- oral swelling and pus discharge
Absence of any systemic disease
Age group between 3-11 years
Malaysian citizen
Exclusion Criteria:
Patients taking antibiotics 30 days prior to their attendance to the department
Presence of any systemic disease
Patients with cellulitis
Patients suffering from spreading odontogenic infections which require hospitalization or immediate IV antibiotic treatment
Tooth with poor prognosis for extraction
Extensively resorbed roots (> 2/3rd)
Patients allergic or resistance to amoxicillin
Non-Malaysian citizen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shani Ann Mani Dr
Organizational Affiliation
Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syarida Hasnur Dr
Organizational Affiliation
Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lily Azura Shoaib Dr
Organizational Affiliation
Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
11059347
Citation
Caufield PW, Griffen AL. Dental caries. An infectious and transmissible disease. Pediatr Clin North Am. 2000 Oct;47(5):1001-19, v. doi: 10.1016/s0031-3955(05)70255-8.
Results Reference
background
PubMed Identifier
15574679
Citation
Nair PN. Pathogenesis of apical periodontitis and the causes of endodontic failures. Crit Rev Oral Biol Med. 2004 Nov 1;15(6):348-81. doi: 10.1177/154411130401500604.
Results Reference
background
PubMed Identifier
19141730
Citation
Robertson D, Smith AJ. The microbiology of the acute dental abscess. J Med Microbiol. 2009 Feb;58(Pt 2):155-162. doi: 10.1099/jmm.0.003517-0.
Results Reference
background
PubMed Identifier
9241924
Citation
Walsh LJ. Serious complications of endodontic infections: some cautionary tales. Aust Dent J. 1997 Jun;42(3):156-9. doi: 10.1111/j.1834-7819.1997.tb00113.x.
Results Reference
background
PubMed Identifier
8734709
Citation
Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.
Results Reference
background
PubMed Identifier
19023306
Citation
Lewis MA. Why we must reduce dental prescription of antibiotics: European Union Antibiotic Awareness Day. Br Dent J. 2008 Nov 22;205(10):537-8. doi: 10.1038/sj.bdj.2008.984.
Results Reference
background
PubMed Identifier
19209291
Citation
Dar-Odeh N, Ryalat S, Shayyab M, Abu-Hammad O. Analysis of clinical records of dental patients attending Jordan University Hospital: Documentation of drug prescriptions and local anesthetic injections. Ther Clin Risk Manag. 2008 Oct;4(5):1111-7. doi: 10.2147/tcrm.s3727.
Results Reference
background
PubMed Identifier
20668712
Citation
Dar-Odeh NS, Abu-Hammad OA, Al-Omiri MK, Khraisat AS, Shehabi AA. Antibiotic prescribing practices by dentists: a review. Ther Clin Risk Manag. 2010 Jul 21;6:301-6. doi: 10.2147/tcrm.s9736.
Results Reference
background
PubMed Identifier
6344030
Citation
Hills-Smith H, Schuman NJ. Antibiotic therapy in pediatric dentistry. II. Treatment of oral infection and management of systemic disease. Pediatr Dent. 1983 Mar;5(1):45-50. No abstract available.
Results Reference
background
PubMed Identifier
25210667
Citation
Bansal R, Jain A. Overview on the current antibiotic containing agents used in endodontics. N Am J Med Sci. 2014 Aug;6(8):351-8. doi: 10.4103/1947-2714.139277.
Results Reference
background
PubMed Identifier
16245464
Citation
Farhad A, Mohammadi Z. Calcium hydroxide: a review. Int Dent J. 2005 Oct;55(5):293-301. doi: 10.1111/j.1875-595x.2005.tb00326.x.
Results Reference
background
PubMed Identifier
16939452
Citation
Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.
Results Reference
background
PubMed Identifier
19678579
Citation
Matijevic S, Lazic Z, Kuljic-Kapulica N, Nonkovic Z. Empirical antimicrobial therapy of acute dentoalveolar abscess. Vojnosanit Pregl. 2009 Jul;66(7):544-50. doi: 10.2298/vsp0907544m.
Results Reference
background
PubMed Identifier
28931398
Citation
Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.
Results Reference
background
PubMed Identifier
11862207
Citation
Siqueira JF Jr, Rocas IN, Lopes HP. Patterns of microbial colonization in primary root canal infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Feb;93(2):174-8. doi: 10.1067/moe.2002.119910.
Results Reference
background
PubMed Identifier
15695744
Citation
Frisch MB, Clark MP, Rouse SV, Rudd MD, Paweleck JK, Greenstone A, Kopplin DA. Predictive and treatment validity of life satisfaction and the quality of life inventory. Assessment. 2005 Mar;12(1):66-78. doi: 10.1177/1073191104268006.
Results Reference
background
PubMed Identifier
3285972
Citation
Locker D. Measuring oral health: a conceptual framework. Community Dent Health. 1988 Mar;5(1):3-18. No abstract available.
Results Reference
background
PubMed Identifier
21330579
Citation
Jackson SL, Vann WF Jr, Kotch JB, Pahel BT, Lee JY. Impact of poor oral health on children's school attendance and performance. Am J Public Health. 2011 Oct;101(10):1900-6. doi: 10.2105/AJPH.2010.200915. Epub 2011 Feb 17.
Results Reference
background
PubMed Identifier
28855834
Citation
Al-Malik M, Al-Sarheed M. Pattern of management of oro-facial infection in children: A retrospective. Saudi J Biol Sci. 2017 Sep;24(6):1375-1379. doi: 10.1016/j.sjbs.2016.03.004. Epub 2016 Mar 31.
Results Reference
background
Links:
URL
http://pdfs.semanticscholar.org/2e49/67ff2f0a06e4b4707d3f0b1436d7b437d91f.pdf
Description
Intra Canal Treatments for Clinical Success and Patient Comfort
URL
http://www.aae.org/specialty/wp-content/uploads/sites/2/2017/06/aae_systemic-antibiotics.pdf
Description
American Association of Endodontics (AAE) Guidance on the Use of Systemic Antibiotics in Endodontics
Learn more about this trial
Systemic and Local Antimicrobials in the Management of Dental Abscess in Children
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