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

Not Applicable

Completed

• Conditions: Alveolar Ridge Abnormality
• Interventions: Other: PRF/ BCP; Other: Autogenous bone graft

• Registration Number: NCT03302429
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-05
• Study Start: 2017-11-19
• Primary Completion: 2023-01-27
• Study Completion: 2023-03-30
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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Exclusion Criteria

• Syndromic cases will be excluded
• Patients suffering from platelets disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF/ BCP	PRF/ BCP	Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF
autogenous bone graft	Autogenous bone graft	Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft

Primary Outcome Measures

Name	Time	Method
bone height	six months postoperative.	the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.

Secondary Outcome Measures

Name	Time	Method
bone volume	six months postoperative.	V= (A1xT) + ( A2 xT) + .......+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices
operation duration	within 4 hours ( the actual number of hours will be determined intra-operative )	It is the time elapsed between using the scalable for incision and the last stitch.; It will be measured by watch in hours.
hospital stay	within 7 days	Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt