Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment (NCT07666932) | Clinical Trial Compass
CompletedNot Applicable
Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment
Jordan64 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Intracanal Bacterial Load
Timeframe: 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.