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

NCT06812351 | Completed Phase 1

• 1 other identifier: RCT1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Root completion of immature teeth

  Root completion of immature teeth will be measured in terms of increase in root length, dentin thickness and apical foramen closure

  1 year follow up

Secondary Outcomes (1)

• positive sensibility test

  1 year follow up

Study Arms (2)

Scaffold with blood clot group

EXPERIMENTAL

root canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization.

Drug: Osteon III collagen

blood clot group

PLACEBO COMPARATOR

root canals were filled with blood clot only after conventional revascularization procedure.

Biological: Blood clot

Interventions

Osteon III collagen DRUG

Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen

Also known as: Double antibiotic liquid

Scaffold with blood clot group

Blood clot BIOLOGICAL

Induction of bleeding from apical papilla

blood clot group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Single rooted immature permanent teeth.
• Symptoms:
• Pulp necrosis either due to infection or trauma.
• Periapical condition; tooth should have periapical radiolucency.
• Tooth should be restorable without the need for further post placement.
• Age: from 6-15 years.
• Sex: males or females.
• Preoperative Cone beam Computed tomography is a must.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university

Cairo, 11, Egypt

Location

MeSH Terms

Interventions

Blood Coagulation

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Abeer Abdelhakim El gendy, PhD

  AinShams University

  STUDY DIRECTOR

• Maram Farouk Obeid, PhD

  AinShams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: February 6, 2025
• Study Start: March 22, 2020
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2022
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)