Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Immature Teeth
- Sponsor
- Damascus University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Clinical evaluation
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:
- What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
- What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Clinical evaluation
Time Frame: 12 months
Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = No Hurt, 1 = Hurts little bit, 2 = hurts Little more 3 = Hurts even more, 4 = Hurts whole lot, and 5 = Hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded.
Radiographical assessment
Time Frame: 12 months
After coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: (1) normal periapical structures (The best); (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; (5) severe periodontitis with exacerbating features (The worst). The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome.