Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment

NCT07623278 | Completed

• 1 other identifier: 265/KEPK FKG-RSGMP UH/EA/IX/20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. The main questions it aims to answer are:

• How does the root canal bacterial profile change before and after irrigation with 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite?
• How does the bacterial profile change after calcium hydroxide medicament is placed in the root canal? Participants will:
• Receive standard root canal treatment with one of two irrigation regimens (5.25 percent or 3 percent sodium hypochlorite, plus EDTA),
• Have root canal samples taken three times (before any treatment, after irrigation, and after calcium hydroxide medicament), and
• Have the bacteria in these samples analyzed using 16S rRNA PCR and DNA sequencing.

Conditions

Root Canal Infection; Chronic Apical Abscess

Keywords

root canal treatment; chronic apical abscess; sodium hypochlorite irrigation; calcium hydroxide; 16S rRNA PCR; root canal microbiota

Outcome Measures

Primary Outcomes (1)

• Change in root canal bacterial community profile

  Bacterial community composition and diversity in root canal samples from molar teeth with chronic apical abscess, assessed using 16S rRNA PCR and DNA sequencing at three time points (before treatment, after irrigation, and after calcium hydroxide medicament).

  Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).

Study Arms (2)

5.25% sodium hypochlorite Irrigation

EXPERIMENTAL

Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 5.25 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament.

Procedure: Root canal treatment with 5.25% sodium hypochlorite irrigation

3% sodium hypochloritel Irrigation

EXPERIMENTAL

Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 3 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament.

Procedure: Root canal treatment with 3% sodium hypochlorite irrigation

Interventions

Root canal treatment with 5.25% sodium hypochlorite irrigation PROCEDURE

Standard root canal procedure in which the canal is irrigated with 5.25 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.

5.25% sodium hypochlorite Irrigation

Root canal treatment with 3% sodium hypochlorite irrigation PROCEDURE

Standard root canal procedure in which the canal is irrigated with 3 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.

3% sodium hypochloritel Irrigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged between 18 and 75 years.
• Physically and mentally able to undergo treatment
• Have not used antibiotics within 1 week before treatment.
• Permanent molar teeth showing clinical and radiographic signs of chronic apical abscess and considered restorable.
• Willing to participate in the study and able to provide written informed consent after receiving an explanation of the study.

You may not qualify if:

• Systemic conditions that require antibiotic prophylaxis for routine dental treatment or other significant systemic disease.
• Pregnant or breastfeeding women.
• Participants with cognitive impairment.
• Teeth with advanced mobility (greater than grade 2).
• Teeth with periodontal pockets deeper than 4 mm.
• Teeth with radiographic signs of root resorption.
• Teeth with calcification or obliteration of the root canal.
• Teeth with root fracture or that fracture during treatment.
• Teeth with open apices.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dental and Oral Hospital Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (2)

• Wang, X., et al. (2023). Longitudinal Analysis of Root Canal Microbiome Using 16S rRNA Sequencing. Journal of Endodontics.

  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 BACKGROUND

Study Officials

• Beatrix Zitzy Uniquen Enoch, DDS

  Dental and Oral Hospital Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Prof. Maria Tanumihardja, DDS, MDS

  Dental and Oral Hospital Hasanuddin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic Resident, Principal Investigator

Model Details: Two parallel groups of adults with chronic apical abscess receive standard root canal treatment with different sodium hypochlorite irrigation concentrations (5.25 percent or 3 percent). Root canal samples are collected three times from the same canal to compare changes in the bacterial community profile over time.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: October 13, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 18, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)