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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-22

Study Completion Date

2022-03-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Randomized Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Scaffold with blood clot group

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

Group Type EXPERIMENTAL

Osteon III collagen

Intervention Type DRUG

Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen

blood clot group

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

Group Type PLACEBO_COMPARATOR

Blood clot

Intervention Type BIOLOGICAL

Induction of bleeding from apical papilla

Interventions

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Osteon III collagen

Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen

Intervention Type DRUG

Blood clot

Induction of bleeding from apical papilla

Intervention Type BIOLOGICAL

Other Intervention Names

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Double antibiotic liquid

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes