Clinical trial NCT03761264: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentoalveolar Abscess
Keywords: Odontogenic Infections
Paediatric Patients
Local Antimicrobials
Systemic Antimicrobials
Dentoalveolar Abscess
Apical Dentoalveolar Abscess
Periapical Abscess
Suppurative Periapical Periodontitis
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Temperature Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Trismus Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Percussion Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Fistula Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7
timeFrame: Baseline, Days 3, 5 or 7
measure: Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7
timeFrame: Baseline, Day 5 or Day 7
measure: Mean change of ECOHIS scores from baseline and at Day 5 or Day 7
timeFrame: Baseline, Day 5 or Day 7
Secondary outcomes:
measure: Quantification of Individual Target Species
timeFrame: First 2 Months of Study
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
name: Shani Ann Mani Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya
name: Syarida Hasnur Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Paediatric Dentistry, Faculty of Dentistry, University of Malaya
name: Lily Azura Shoaib Dr
role: PRINCIPAL_INVESTIGATOR
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