Minimally invasive root canal treatment with heated sodium hypochlorite for tooth healing
Minimal Instrumentation With Intracanal Heating ad Activation of Sodium Hypochlorite for
NA · Saint-Joseph University · NCT06461728
This study is testing a new way to do root canal treatment using heated sodium hypochlorite to see if it helps heal single-rooted teeth better than the traditional method for people with tooth pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint-Joseph University (other) |
| Locations | 1 site (Beirut) |
| Trial ID | NCT06461728 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a minimally invasive approach to root canal treatment that combines intracanal heating and activation of sodium hypochlorite in treating asymptomatic apical periodontitis in single-rooted teeth. A total of 32 teeth will be randomly assigned to either a conventional or conservative technique group. The conventional group will utilize rotary instrumentation and standard sodium hypochlorite irrigation, while the conservative group will employ a prototype device for heating and activating the sodium hypochlorite. The study aims to assess the healing outcomes based on clinical and radiological evaluations.
Who should consider this trial
Good fit: Ideal candidates include healthy adults with single-rooted teeth exhibiting pulp necrosis and asymptomatic apical periodontitis.
Not a fit: Patients with multiple canals, previous root canal treatments, or significant anatomical variations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes for patients with periapical lesions and reduce the need for more invasive procedures.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in improving endodontic outcomes through advanced irrigation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy patients without any known allergic reactions or systemic diseases. * Single rooted teeth. * Fully formed roots. * The ability to place #15 hand file to working length (WL). * Absence of canal calcifications. * Absence of root fracture. * Absence of resorption. * Teeth with pre-operative periapical radiolucency and PAI score ≥ 3 according to the classification of Ørstavik et al. 1986(20). * Estimated WL 20-23mm. Exclusion Criteria: * Roots with broken or immature open apices. * Roots presenting resorption. * Patients younger than 18 years old. * Pregnant patients. * Teeth with previous root canal treatment. * Teeth with calcified canals. * Teeth with two canals or any other anatomic variations. * Root length less than 16 mm. * Patients with chronic generalized periodontitis. * Teeth with caries affecting the roots. * Abnormal mobility of the tooth. * Extensively restored and prepared teeth. * Open apices. * Previously root canal therapy. * Root cracks.
Where this trial is running
Beirut
- Saint Joseph University — Beirut, Lebanon (RECRUITING)
Study contacts
- Study coordinator: Fabienne Roukoz El Jagi, MSc
- Email: fabienne.jagi@net.usj.edu.lb
- Phone: 70510337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heating and Activation of Sodium Hypochlorite