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

February 1, 2025 updated by: Menna Ali, Ain Shams University

Clinical and Radiographic Outcome of Regenerative Endodontic Treatment in Immature Permanent Human Teeth Using a Collagen Hydroxyapatite Scaffold

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11
        • AinShams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scaffold with blood clot group
root canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization.
Drug: Osteon III collagen
Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen
Other Names:
  • Double antibiotic liquid
Placebo Comparator: blood clot group
root canals were filled with blood clot only after conventional revascularization procedure.
Biological: Blood clot
Induction of bleeding from apical papilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root completion of immature teeth
Time Frame: 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
1 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
positive sensibility test
Time Frame: 1 year follow up
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Abeer Abdelhakim El gendy, PhD, AinShams University
  • Study Director: Maram Farouk Obeid, PhD, AinShams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2020

Primary Completion (Actual)

March 22, 2021

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 1, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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