Systemic and Local Antimicrobials in the Management of Dental Abscess in Children

University of Malaya

Status and phase: Completed; Phase 2

Conditions: Dentoalveolar Abscess

Treatments: Drug: Odontopaste®; Drug: Pulpdent; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT03761264

RP053A-17HTM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

Intra-canal Odontopaste®

Experimental group

Description:

Single visit placement of Odontopaste®

Treatment:

Drug: Odontopaste®

Intra-canal Pulpdent

Active Comparator group

Description:

Single visit placement of Pulpdent

Treatment:

Drug: Pulpdent

Oral Amoxicillin

Active Comparator group

Description:

Amoxicillin 15mg/kg tds for 5 days

Treatment:

Drug: Amoxicillin