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Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment (BactProfil-RCT)

3 juni 2026 bijgewerkt door: Beatrix Zitzy Uniquen Enoch, Hasanuddin University

Bacterial Profile Changes During Root Canal Treatment With 5.25% and 3% Sodium Hypochlorite Irrigation and Calcium Hydroxide Medicament Assessed by 16S rRNA PCR

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Chronic apical abscess is associated with complex multispecies biofilms in the root canal that can differ between populations and are not fully characterized by conventional culture methods. This study focuses on adult patients with necrotic molar teeth and chronic apical abscess treated at the Dental and Oral Hospital, Faculty of Dentistry, Hasanuddin University. The main objective is to describe how the root canal bacterial community profile changes during different phases of routine root canal treatment using 16S rRNA PCR and sequence analysis.

The study uses a descriptive and analytic repeated-measures design. At least 24 adult outpatients with necrotic pulp and chronic apical abscess who meet the inclusion and exclusion criteria will be recruited and provide written informed consent. After rubber dam isolation, access cavity preparation, and working length determination, the first root canal sample (S1) is collected from the distal canal using a sterile Hedström file and transferred into a tube containing DNA preservative solution. Mechanical preparation is then performed with rotary instruments. Patients are randomly assigned by clinic staff, who are blinded to the investigator, to one of two irrigation regimens: 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite, each followed by sterile distilled water, 17 percent EDTA, and a final rinse with sterile distilled water. A second sample (S2) is collected from the same canal after irrigation. Calcium hydroxide intracanal medicament is then placed and the tooth is temporized.

After approximately two weeks, the temporary restoration and calcium hydroxide are removed, and a third sample (S3) is collected from the same canal using a sterile Hedström file. All samples are stored in DNA preservative solution and analyzed by 16S rRNA PCR followed by DNA sequencing to characterize the bacterial community composition and diversity. The study will compare bacterial taxa and community profiles at S1, S2, and S3 and between the two sodium hypochlorite concentrations in order to explore how root canal irrigation and calcium hydroxide medicament are associated with changes in the bacterial community.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indonesië
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesië, 90245
        • Dental and Oral Hospital Hasanuddin University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 5.25% sodium hypochlorite Irrigation
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
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.
Experimenteel: 3% sodium hypochloritel Irrigation
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
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in root canal bacterial community profile
Tijdsspanne: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).
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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hasanuddin University

Onderzoekers

  • Hoofdonderzoeker: Beatrix Zitzy Uniquen Enoch, DDS, Dental and Oral Hospital Hasanuddin University
  • Studie directeur: Prof. Maria Tanumihardja, DDS, MDS, Dental and Oral Hospital Hasanuddin University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 oktober 2025

Primaire voltooiing (Werkelijk)

30 maart 2026

Studie voltooiing (Werkelijk)

18 mei 2026

Studieregistratiedata

Eerst ingediend

28 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 265/KEPK FKG-RSGMP UH/EA/IX/20

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because of privacy considerations and institutional and ethics committee policies that restrict sharing of identifiable clinical data outside the study team.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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