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

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Randomized Clinical Trial

Treatments: Drug: Osteon III collagen; Biological: Blood clot

Study type: Interventional

Funder types: Other

Identifiers

NCT06812351

RCT1

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Scaffold with blood clot group

Experimental group

Description:

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

Treatment:

Drug: Osteon III collagen

blood clot group

Placebo Comparator group

Description:

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

Treatment:

Biological: Blood clot