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Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft

NCT ID: NCT03302429

Last Updated: 2024-11-04

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

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-19

Study Completion Date

2023-03-30

Brief Summary

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P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.

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Detailed Description

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this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch

Conditions

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Alveolar Ridge Abnormality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eighteen patients will be divided into two equal groups. Each group comprises nine patients.

Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRF/ BCP

Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF

Group Type EXPERIMENTAL

PRF/ BCP

Intervention Type OTHER

Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)

autogenous bone graft

Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft

Group Type ACTIVE_COMPARATOR

Autogenous bone graft

Intervention Type OTHER

Bone obtained from the same individual who receiving the graft

Interventions

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PRF/ BCP

Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)

Intervention Type OTHER

Autogenous bone graft

Bone obtained from the same individual who receiving the graft

Intervention Type OTHER

Other Intervention Names

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Easy-graft/BCP

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from maxillary alveolar cleft
* Patients' age 8 years and older

Exclusion Criteria

* Syndromic cases will be excluded
* Patients suffering from platelets disorders.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hebatallah G Samra El-Shamy

resarcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2017-09-31

Identifier Type: -

Identifier Source: org_study_id

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