Bacterial Profiles in Primary Apical Periodontitis Using 16S rRNA PCR

NCT07637305 | Completed

• 1 other identifier: 265/KEPK FKG-RSGMP UH/EA/I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periapical Periodontitis; Root canal infection; Sodium Hypochlorite; Calcium Hydroxide; Polymerase Chain Reaction; RNA, Ribosomal, 16S; DNA, Bacterial; Molecular Diagnostic Techniques

Outcome Measures

Primary Outcomes (1)

• Detection of Bacterial DNA in Root Canal Samples

  The presence or absence of detectable bacterial DNA will be assessed using 16S rRNA PCR sequencing in distal root canal samples collected before treatment, after sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication.

  Baseline, immediately after irrigation, and 2 weeks after intracanal calcium hydroxide medication

Secondary Outcomes (1)

• Bacterial Profile Changes During Endodontic Treatment

  Baseline, immediately after irrigation, and 2 weeks after intracanal calcium hydroxide medication

Study Arms (4)

Symptomatic Apical Periodontitis with 3% Sodium Hypochlorite

EXPERIMENTAL

Participants with mandibular first molars diagnosed with symptomatic primary apical periodontitis will receive root canal treatment with 3% sodium hypochlorite irrigation.

Drug: 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Symptomatic Apical Periodontitis with 5.25% Sodium Hypochlorite

EXPERIMENTAL

Participants with mandibular first molars diagnosed with symptomatic primary apical periodontitis will receive root canal treatment with 5.25% sodium hypochlorite irrigation.

Drug: 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Asymptomatic Apical Periodontitis with 3% Sodium Hypochlorite

EXPERIMENTAL

Participants with mandibular first molars diagnosed with asymptomatic primary apical periodontitis will receive root canal treatment with 3% sodium hypochlorite irrigation.

Drug: 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Asymptomatic Apical Periodontitis with 5.25% Sodium Hypochlorite

EXPERIMENTAL

Participants with mandibular first molars diagnosed with asymptomatic primary apical periodontitis will receive root canal treatment with 5.25% sodium hypochlorite irrigation.

Drug: 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation

Interventions

5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation DRUG

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.

Asymptomatic Apical Periodontitis with 5.25% Sodium Hypochlorite; Symptomatic Apical Periodontitis with 5.25% Sodium Hypochlorite

3% Sodium Hypochlorite Irrigation with Ultrasonic Activation DRUG

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.

Asymptomatic Apical Periodontitis with 3% Sodium Hypochlorite; Symptomatic Apical Periodontitis with 3% Sodium Hypochlorite

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients who are mentally and physically healthy, aged 18-40 years.
• Mature permanent molar teeth diagnosed with symptomatic or asymptomatic apical periodontitis, determined based on:
• Patient history; Intraoral clinical examination; For symptomatic apical periodontitis: negative pulp vitality test, negative palpation test, positive percussion test, with or without widening of the periodontal ligament space; For asymptomatic apical periodontitis: negative pulp vitality test, negative palpation test, percussion test findings, and radiographic assessment using a periapical index score of less than 5 based on periapical radiographs.
• Teeth with straight root canals. Teeth that are restorable after root canal treatment. Patients who are willing to participate in the study and have signed the informed consent form after receiving an explanation of the study.

You may not qualify if:

• Participants will be excluded if the tooth or patient presents with any of the following conditions:
• Patients who have taken antibiotics within 7 days before sample collection. Advanced tooth mobility greater than grade 2. Periodontal pockets greater than 4 mm. Teeth with previous endodontic treatment. Root fracture or fracture occurring during root canal treatment. Teeth showing internal or external resorption. Teeth with open apices. Teeth with calcified or obliterated root canals. Patients with systemically compromised conditions requiring antibiotic coverage for routine dental treatment or patients with systemic diseases.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dental and Oral Hospital of Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (2)

• Alquria TA, Acharya A, Tordik P, Griffin I, Martinho FC. Impact of root canal disinfection on the bacteriome present in primary endodontic infection: A next generation sequencing study. Int Endod J. 2024 Aug;57(8):1124-1135. doi: 10.1111/iej.14074. Epub 2024 May 3.

  PMID: 38700876 BACKGROUND

• Siqueira JF Jr, Rocas IN. Present status and future directions: Microbiology of endodontic infections. Int Endod J. 2022 May;55 Suppl 3:512-530. doi: 10.1111/iej.13677. Epub 2022 Jan 13.

  PMID: 34958494 RESULT

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Juwita Purnamasari, DDS

  Dental and Oral Hospital Hasanuddin University, Makassar, South Sulawesi, Indonesia, 90245

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation of sodium hypochlorite concentration will be performed randomly by a dental nurse and will not be known by the researcher during sample allocation. No participant masking is applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic Resident

Model Details: Participants with mandibular first molars diagnosed with symptomatic or asymptomatic primary apical periodontitis will be assigned to receive root canal irrigation using either 3% sodium hypochlorite or 5.25% sodium hypochlorite during endodontic treatment. Microbial samples will be collected from the distal root canal before treatment, after chemomechanical preparation and sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication. Bacterial profiles will be identified using 16S rRNA polymerase chain reaction sequencing.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: October 13, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)