NCT07637305 — drugset

Summary

This pilot randomized clinical study aims to compare bacterial profiles in symptomatic and asymptomatic primary apical periodontitis using 16S rRNA polymerase chain reaction sequencing. Twenty-four mandibular first molars requiring endodontic treatment will be selected from patients attending the Conservative Dentistry Clinic at the Dental and Oral Hospital of Hasanuddin University. The samples will be divided into two diagnostic groups: symptomatic primary apical periodontitis and asymptomatic primary apical periodontitis. Each diagnostic group will then be allocated into two irrigation groups using either 3% or 5.25% sodium hypochlorite. Microbial samples will be collected from the distal root canal at three time points: before root canal treatment, after chemomechanical preparation and sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication. Root canal samples will be subjected to bacterial DNA extraction, 16S rRNA PCR amplification, sequencing, and taxonomic identification. The primary outcome is the presence or absence of detectable bacterial DNA at each sampling stage. Secondary outcomes include the bacterial taxa identified in symptomatic and asymptomatic primary apical periodontitis and changes in bacterial profiles after sodium hypochlorite irrigation and calcium hydroxide medication. The study is designed to provide preliminary clinical-molecular evidence on bacterial profile changes during endodontic treatment of primary apical periodontitis.

Timeline

Start: 2025-10-13
Primary completion: 2026-02-28
Completion: 2026-03-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Hypochlorite	Unknown	3 %	Other
Subject	Sodium Hypochlorite	Unknown	5.25 %	Other

Bacterial Profiles in Primary Apical Periodontitis Using 16S rRNA PCR

Summary

Timeline

Publications

Drugs

Indications