Comparing techniques for treating necrotic immature incisors
Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
This study is testing which of three different treatments works best for kids with damaged front teeth to help them heal and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 7 Years to 11 Years |
| Sex | All |
| Sponsor | Damascus University Academic / other |
| Locations | 1 site (Damascus) |
| Trial ID | NCT06119477 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify the most effective bioceramic apexification techniques for children with necrotic maxillary incisors. Participants will undergo one of three procedures: Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, or a Combination of both. The study will evaluate post-operative pain, periapical healing, bioceramics extrusion, and the time required for each technique. Follow-up appointments will include clinical and radiological evaluations to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are children with necrotic maxillary incisors that have an open apex and evidence of chronic apical periodontitis.
Not a fit: Patients with systemic diseases affecting their immune status or those with unrestorable incisors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for children with necrotic immature incisors, reducing pain and enhancing healing.
How similar studies have performed: While similar techniques have been explored, this specific comparison of bioceramic apexification methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm. Exclusion Criteria: * Children with systemic diseases that compromised their general immune status. * Uncooperative (definitely negative on the Frankl's behavioral scale). * unrestorable incisors.
Where this trial is running
Damascus
- Damascus University — Damascus, Syrian Arab Republic (Recruiting)
Study contacts
- Study coordinator: Yasser Alsayed Tolibah, PhD Student
- Email: yasseralsayedtolibah@gmail.com
- Phone: 00963988812044
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.