Bacterial Profiles in Primary Apical Periodontitis Using 16S rRNA PCR

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.

Conditions

• Primary Apical Periodontitis
• Root Canal Infection
• Endodontic Infection

Interventions

DRUG

3% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Root canals will be prepared using rotary ProTaper Gold instruments up to F2. Irrigation will be performed using 3% sodium hypochlorite, followed by sterile distilled water, 17% EDTA, and sterile distilled water. The irrigant will be activated ultrasonically for 20 seconds per cycle for three cycles. Microbial samples will be collected before treatment, after irrigation, and two weeks after calcium hydroxide intracanal medication.

DRUG

5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Root canals will be prepared using rotary ProTaper Gold instruments up to F2. Irrigation will be performed using 5.25% sodium hypochlorite, followed by sterile distilled water, 17% EDTA, and sterile distilled water. The irrigant will be activated ultrasonically for 20 seconds per cycle for three cycles. Microbial samples will be collected before treatment, after irrigation, and two weeks after calcium hydroxide intracanal medication.

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• Juwita Purnamasari, DDS · Dental and Oral Hospital Hasanuddin University, Makassar, South Sulawesi, Indonesia, 90245

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-13

Primary Completion

2026-02-28

Completion

2026-03-31

Countries

• Indonesia

Study Locations