Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth
- Conditions
- Periapical Periodontitis
- Interventions
- Procedure: Mineral trioxide aggregateProcedure: Premixed Bioceramic Putty
- Registration Number
- NCT06322979
- Lead Sponsor
- Tanta University
- Brief Summary
Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- nonvital immature permanent teeth as a consequence of trauma or dental caries
- nonvital permanent teeth with radiographic evidence of immature root end development
- clinically restorable teeth
- immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
- Immature nonvital permanent teeth associated with developmental abnormalities.
- Patients with a history of systemically debilitating diseases
- unrestorable remaining crown structure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MTA group Mineral trioxide aggregate After the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite. Premixed Bioceramic Putty group Premixed Bioceramic Putty After the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
- Primary Outcome Measures
Name Time Method the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) up to 12 months The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) at 6 and12 months follow up The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption.
The apexification procedure will be radiographically unsuccessful if the apical lesion size increases.
The apexification procedure will be doubtful if the apical lesion size doesn't change
- Secondary Outcome Measures
Name Time Method Change in the periapical index (PAI) at 6 and12 months follow up Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, Gharbia, Egypt