Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth

Not Applicable

Recruiting

• Conditions: Incomplete Root Formation of Anterior Teeth

• 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.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2022-12-10
• Status Verified: 2023-03
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Primary Completion: 2023-08-15
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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

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
visual changes in discoloration	1 year
Pain scale	1 year

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt