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

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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Dental Pulp Necrosis
• Intervention / Treatment: Procedure: Sodium Hypochlorite Irrigation; Procedure: Sodium Hypochlorite Irrigation Plus Photodynamic Therapy; Procedure: Photodynamic Therapy Adjunct Evaluation; Other: Saline Irrigation Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • University of Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Experimental: 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.
Experimental: 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 Comparator: 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.	Other: Saline Irrigation Control; Sterile 0.9% saline irrigation used as a negative-control procedure before microbiological sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intracanal Bacterial Load	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity From Baseline to 24 Hours After 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

Collaborators and Investigators

• Sponsor: Bayan Alqrenawi

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Photodynamic therapy; Sodium hypochlorite; Bacterial reduction; Antimicrobial photodynamic therapy
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Periodontitis; Pathological Conditions, Signs and Symptoms; Periapical Periodontitis; Dental Pulp Necrosis; Therapeutics; Drug Therapy; Combined Modality Therapy; Phototherapy; Photochemotherapy
• Other Study ID Numbers: 10/2025/5586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated and analyzed study results may be reported in the thesis, scientific presentations, or publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No