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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06812351

Enrollment

Registered

2025-02-06

Start date

2020-03-22

Completion date

2022-03-22

Last updated

2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Randomized Clinical Trial

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.

Interventions

DRUGOsteon III collagen

Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen

BIOLOGICALBlood clot

Induction of bleeding from apical papilla

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
positive sensibility test	1 year follow up

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026