Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth
- Conditions
- Incomplete Root Formation of Anterior Teeth
- Interventions
- Other: Intra-canal medication protocol
- Registration Number
- NCT05803525
- Lead Sponsor
- Tanta University
- Brief Summary
The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.
- Detailed Description
Patients will be divided randomly into six equal groups (n=8)
* Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows
1. Score 0: Persistence of clinical and radiographic findings.
2. Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
3. Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
-
• Patients, abarantly free from any systemic diseases that may hinder the normal healing process.
- Maxillary traumatized or cariously exposed immature anterior teeth.
- Clinical signs of pulp necrosis.
- Radiographic evidence of incomplete root development based on an apical opening >1 mm.
-
• Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense).
- Non-restorable tooth.
- Radiographic evidence of root fracture.
- Lack of patient and parent cooperation.
- Teeth with vital pulps and complete root development.
- Presence of periodontal pocket > 4 mm.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description • Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. • Intra-canal medication protocol BC will be made \& use 2.5 NaOCl conc • Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution. Intra-canal medication protocol BC will be made \& use 0.5 NaOCl conc • Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. • Intra-canal medication protocol PRF will be made \& use 0.5 NaOCl conc • Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution. Intra-canal medication protocol Collagen will be made \& use 2.5 NaOCl conc Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. • Intra-canal medication protocol PRF will be made \& use 2.5 NaOCl conc • Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution. Intra-canal medication protocol Collagen will be made \& use 0.5 NaOCl conc
- Primary Outcome Measures
Name Time Method diameter of periapical radiolucency 1 year radiographic changes in root
diameter of root length 1 year radiographic changes in root
- Secondary Outcome Measures
Name Time Method Pain scale 1 year visual changes in discoloration 1 year
Trial Locations
- Locations (1)
Faculty of Dentistry, Tanta University
🇪🇬Tanta, Egypt