Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold

Phase 1

Completed

• Conditions: Randomized Clinical Trial
• Interventions: Drug: Osteon III collagen; Biological: Blood clot

• Registration Number: NCT06812351
• Lead Sponsor: Ain Shams University

Brief Summary

This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:

1. Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.

2. Conventional blood clot scaffold.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-22
• Primary Completion: 2021-03-22
• Study Completion: 2022-03-22
• Study First Submitted: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-01
• Last Update Submitted: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Single rooted immature permanent teeth.

2. Symptoms:

   1. Pulp necrosis either due to infection or trauma.
   2. Periapical condition; tooth should have periapical radiolucency.

3. Tooth should be restorable without the need for further post placement.

4. Age: from 6-15 years.

5. Sex: males or females.

6. Preoperative Cone beam Computed tomography is a must.

Exclusion Criteria

• Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaffold with blood clot group	Osteon III collagen	root canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization.
blood clot group	Blood clot	root canals were filled with blood clot only after conventional revascularization procedure.

Primary Outcome Measures

Name	Time	Method
Root completion of immature teeth	1 year follow up	Root completion of immature teeth will be measured in terms of increase in root length, dentin thickness and apical foramen closure

Secondary Outcome Measures

Name	Time	Method
positive sensibility test	1 year follow up

Trial Locations

Locations (1)

AinShams university; 🇪🇬 Cairo, Egypt