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.
Age range
3 Years – 11 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Temperature Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Trismus Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Percussion Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Fistula Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7
Timeframe: Baseline, Days 3, 5 or 7
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
Mean change of ECOHIS scores from baseline and at Day 5 or Day 7
Timeframe: Baseline, Day 5 or Day 7