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Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment (PDT-NaOCl)

27. juni 2026 opdateret af: Bayan Alqrenawi

A Comparison Study of the Antimicrobial Efficacy of Sodium Hypochlorite and Sodium Hypochlorite Supplemented With Photodynamic Therapy in Eliminating Bacteria in Primary Root Canal Treatment: An In Vivo Study

This clinical study will compare different root canal disinfection methods used during primary root canal treatment. Root canal infection is mainly caused by bacteria inside the root canal system. Sodium hypochlorite is commonly used as a root canal irrigant because it helps reduce bacteria. Photodynamic therapy is an additional disinfection method that uses a photosensitizing solution and light activation to help kill bacteria. Participants who need primary root canal treatment will be randomly assigned to one of the study groups. The study will compare sodium hypochlorite irrigation alone with sodium hypochlorite supplemented with photodynamic therapy. Additional comparison groups will be used to assess the antimicrobial effect of the disinfection procedures. Bacterial samples will be collected from the root canals before and after the assigned disinfection protocol to measure the reduction in bacterial counts. The main outcome of the study is the reduction in intracanal bacterial load after the disinfection procedure. Postoperative pain will also be assessed using a visual analogue scale at selected time points after treatment. All participants will receive standard root canal treatment, and the final clinical disinfection and treatment procedures will be completed according to accepted endodontic practice.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an in vivo randomized clinical study designed to evaluate the antimicrobial effect of root canal disinfection protocols during primary root canal treatment. The study focuses on the reduction of viable intracanal bacteria following irrigation with sodium hypochlorite, with or without adjunctive photodynamic therapy. Eligible participants requiring primary root canal treatment will be enrolled and randomly allocated to one of the study groups according to the approved protocol. Under rubber dam isolation, root canal treatment will be performed using standard endodontic procedures. Intracanal microbiological samples will be collected using sterile paper points before and after the assigned disinfection protocol. The collected samples will be processed for culture-based microbiological analysis, and bacterial reduction will be assessed by comparing viable bacterial counts before and after the intervention. Photodynamic therapy will be used as an adjunctive disinfection method in the relevant study group. This technique involves the use of a photosensitizing agent followed by activation with light of an appropriate wavelength to produce an antimicrobial effect. Sodium hypochlorite irrigation will be used as the standard chemical disinfection method. For ethical and clinical safety reasons, all participants will receive completion of treatment according to accepted endodontic standards. Postoperative pain will be recorded after treatment using a visual analogue scale. The study is intended to determine whether adding photodynamic therapy to sodium hypochlorite improves intracanal bacterial reduction compared with sodium hypochlorite irrigation alone during primary root canal treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Jordan
      • Amman, Jordan
        • University of Jordan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients aged 18 to 70 years.
  • Medically healthy patients or patients with well-controlled systemic conditions, such as controlled diabetes or controlled hypertension.
  • Patients requiring primary root canal treatment in mature, single-rooted, single-canal teeth.
  • Teeth with a confirmed diagnosis of pulp necrosis, with or without apical periodontitis.
  • Teeth that are restorable.
  • Teeth suitable for single-visit root canal treatment.
  • Teeth suitable for rubber dam isolation.
  • Cases with dry canals that do not require inter-appointment medication.
  • Participants who provide written informed consent before treatment.

Exclusion Criteria:

  • Patients with uncontrolled systemic disease.
  • Patients with immunocompromised status.
  • Patients with any condition that could affect infection, healing, or treatment response.
  • Patients who used systemic antibiotics within the previous three months.
  • Patients who used analgesic or anti-inflammatory medication shortly before treatment.
  • Pregnant or lactating patients.
  • Patients with known allergy or contraindication to any study material.
  • Teeth with irreversible pulpitis.
  • Teeth with previous root canal treatment or retreatment indication.
  • Teeth with immature apices.
  • Teeth with internal or external root resorption.
  • Teeth with cracks, fractures, or perforations.
  • Teeth with unusual canal anatomy that could prevent procedural standardization.
  • Teeth with advanced periodontal involvement.
  • Teeth with unrestorable coronal structure.
  • Canals with persistent exudate.
  • Cases with acute swelling or acute abscess.
  • Any condition requiring multi-visit treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sodium Hypochlorite Irrigation
Participants assigned to this arm will receive root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment.
Procedure: Sodium Hypochlorite Irrigation
Root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment.
Eksperimentel: Sodium Hypochlorite Plus Photodynamic Therapy
Participants assigned to this arm will receive 3% sodium hypochlorite irrigation supplemented with adjunctive photodynamic therapy during primary root canal treatment.
Procedure: Sodium Hypochlorite Irrigation Plus Photodynamic Therapy
Root canal disinfection using 3% sodium hypochlorite irrigation followed by adjunctive photodynamic therapy using a photosensitizing agent and light activation.
Eksperimentel: Photodynamic Therapy Adjunct Evaluation
Participants assigned to this arm will receive photodynamic therapy as the assigned antimicrobial evaluation step, followed by completion of standard root canal disinfection and treatment according to the approved protocol.
Procedure: Photodynamic Therapy Adjunct Evaluation
Antimicrobial photodynamic therapy using a photosensitizing agent and light activation as an adjunctive disinfection evaluation step during primary root canal treatment.
Placebo komparator: Saline Control
Participants assigned to this arm will receive sterile saline irrigation as a negative-control procedure before microbiological sampling, followed by completion of standard root canal disinfection and treatment according to the approved protocol.
Andet: Saline Irrigation Control
Sterile 0.9% saline irrigation used as a negative-control procedure before microbiological sampling.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intracanal Bacterial Load
Tidsramme: From baseline intracanal sampling before the assigned disinfection protocol to immediately after completion of the assigned disinfection protocol during the same root canal treatment visit.
Intracanal bacterial load will be assessed using culture-based microbiological analysis of root canal samples collected with sterile paper points. Viable bacterial counts will be expressed as log10 colony-forming units (CFU). The primary outcome will be the reduction in bacterial load, calculated as the difference between baseline log10 CFU and post-disinfection log10 CFU values.
From baseline intracanal sampling before the assigned disinfection protocol to immediately after completion of the assigned disinfection protocol during the same root canal treatment visit.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity From Baseline to 24 Hours After Root Canal Treatment
Tidsramme: Baseline before treatment and 24 hours after completion of root canal treatment
Pain intensity will be assessed using a 10-cm visual analogue scale. Participants will record their pain level before treatment and 24 hours after treatment. The change in pain score will be calculated by comparing the baseline preoperative pain score with the 24-hour postoperative pain score.
Baseline before treatment and 24 hours after completion of root canal treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayan Alqrenawi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. maj 2025

Primær færdiggørelse (Faktiske)

20. april 2026

Studieafslutning (Faktiske)

20. april 2026

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10/2025/5586

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared. Only aggregated and analyzed study results may be reported in the thesis, scientific presentations, or publications.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Apikal parodontitis

Kliniske forsøg med Sodium Hypochlorite Irrigation

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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