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, medically healthy or with well-controlled conditions like diabetes or hypertension, needing primary root canal treatment in mature, single-rooted, single-canal teeth were eligible. Teeth required a confirmed pulp necrosis diagnosis, with or without apical periodontitis, and had to be restorable, suitable for single-visit treatment, and amenable to rubber dam isolation. Only cases with dry canals not needing inter-appointment medication were included. All participants provided written informed consent before treatment. Exclusion Criteria: * Patients were excluded if they had uncontrolled systemic disease, immunocompromised status, or any condition affecting infection, healing, or treatment response. Patients who used systemic antibiotics in the previous three months, or took analgesic or anti-inflammatory medication shortly before treatment, were excluded to prevent interference with microbiological or postoperative pain outcomes. Pregnancy, lactation, and known allergy or contraindication to any study material were additional exclusion criteria per institutional requirements. Teeth were excluded if they had irreversible pulpitis, a history of previous or retreatment indication, immature apices, internal or external root resorption, cracks, fractures, perforations, unusual canal anatomy precluding procedural standardisation, advanced periodontal involvement, or unrestorable coronal structure. Canals with persistent exudate, acut…

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

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.

Trial details

NCT IDNCT07666932

SponsorBayan Alqrenawi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

View on ClinicalTrials.gov More Dental Pulp Necrosis trials