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Completed

NCT Number: NCT07666932

Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Hypochlorite Irrigation

Procedure

Root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment.

Sodium Hypochlorite Irrigation Plus Photodynamic Therapy

Procedure

Root canal disinfection using 3% sodium hypochlorite irrigation followed by adjunctive photodynamic therapy using a photosensitizing agent and light activation.

Photodynamic Therapy Adjunct Evaluation

Procedure

Antimicrobial photodynamic therapy using a photosensitizing agent and light activation as an adjunctive disinfection evaluation step during primary root canal treatment.

Saline Irrigation Control

Other

Sterile 0.9% saline irrigation used as a negative-control procedure before microbiological sampling.

Primary outcomes

  1. Change in Intracanal Bacterial Load

    Time frame: 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.

Secondary outcomes

  1. Change in Pain Intensity From Baseline to 24 Hours After Root Canal Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayan Alqrenawi

Other

Registry information

Official study title

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

Acronym: PDT-NaOCl

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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