Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment

NCT07666932 | Completed

• 1 other identifier: 10/2025/5586
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Pulp Necrosis; Apical Periodontitis

Keywords

Photodynamic therapy; Antimicrobial photodynamic therapy; Sodium hypochlorite; Bacterial reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline before treatment and 24 hours after completion of root canal treatment

Study Arms (4)

Sodium Hypochlorite Irrigation

EXPERIMENTAL

Participants assigned to this arm will receive root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment.

Procedure: Sodium Hypochlorite Irrigation

Sodium Hypochlorite Plus Photodynamic Therapy

EXPERIMENTAL

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

Photodynamic Therapy Adjunct Evaluation

EXPERIMENTAL

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

Saline Control

PLACEBO COMPARATOR

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

Interventions

Saline Irrigation Control OTHER

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

Saline Control

Sodium Hypochlorite Irrigation PROCEDURE

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

Sodium Hypochlorite Irrigation

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.

Sodium Hypochlorite Plus Photodynamic Therapy

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.

Photodynamic Therapy Adjunct Evaluation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayan Alqrenawi: lead

Study Sites (1)

University of Jordan

Amman, Jordan

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: master's degree student

Model Details: Participants will be randomly assigned in a parallel-group design to one of the study intervention groups. Each participant will receive only the assigned root canal disinfection protocol, and there will be no crossover between groups.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: May 19, 2025
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)