Non-surgical retreatment for root canal issues using bioceramic sealer

Outcome Of Non-Surgical Single Visit Endodontic Retreatment in Teeth With Asymptomatic Apical Periodontitis Using Bioceramic Sealer (A Randomized Controlled Clinical Trial)

This study is testing if a new bioceramic sealer works better than traditional resin sealers for fixing root canal problems in a single visit for patients with a specific type of tooth issue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Alexandria University (Academic / other)
• Locations: 2 sites (Alexandria and 1 other locations)
• Trial ID: NCT06973135 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of bioceramic sealers in non-surgical single visit endodontic retreatment for patients with asymptomatic apical periodontitis compared to traditional resin sealers. Participants will undergo root canal retreatment in a single visit, followed by follow-up assessments at 1, 3, 6, and 12 months to monitor healing and postoperative pain. The study will utilize periapical radiographs and cone beam computed tomography (CBCT) to measure lesion size and healing progress. Pain assessments will be conducted at various intervals post-treatment to gauge patient comfort and recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with mandibular molar teeth that have previously undergone unsuccessful endodontic treatment and present with asymptomatic apical periodontitis.

Not a fit: Patients with teeth requiring retreatment with a poor prognosis or those with systemic disorders affecting bone metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced postoperative pain for patients undergoing root canal retreatment.

How similar studies have performed: While the use of bioceramic sealers in endodontics is gaining attention, this specific approach in a single visit retreatment setting is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis.
2. Teeth with inadequate obturation.
3. Teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex.
4. Teeth with periapical lesion.
5. Patient with the ages of 18-65 years.
6. Patient medically healthy and free from systemic diseases or with mild controlled systemic disease. ASA I, II \* (52).
7. Patient with no acute pain or extraoral swelling.
8. Patients who agreed to participate in the study and attend the control visits.

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Exclusion Criteria:

1. Teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation)
2. Teeth with vertical root fracture or open apex.
3. Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism.
4. Pregnant patients.
5. Patient under antibiotics treatment 2 weeks before the treatment.
6. Patients who could not attend follow up will be excluded from the study

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Where this trial is running

Alexandria and 1 other locations

• faculty of dentistry Alexandria university — Alexandria, Egypt (Recruiting)
• faculty of dentistry Alexandria university — Alexandria, Egypt (Recruiting)

Study contacts

• Study coordinator: sally M Nazir, Master

Conditions Asymptomatic Apical Periodontitis; Root Canal Retreatment; CBCT; secondary root canal treatment; asymptomatic apical periodontitis; bioceramic sealer