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OpenTrials
Completed

NCT Number: NCT06812351

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

Completed

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Key information

Conditions

Randomized Clinical Trial

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AinShams university

Cairo, 11, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Osteon III collagen

Drug

Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen

Other names: Double antibiotic liquid

Blood clot

Biological

Induction of bleeding from apical papilla

Primary outcomes

  1. 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

Secondary outcomes

  1. positive sensibility test

    Time frame: 1 year follow up

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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