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

Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Abnormality
• Intervention / Treatment: Other: PRF/ BCP; Other: Autogenous bone graft

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3311
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF/ BCP; Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF	Other: PRF/ BCP; Platelet rich fibrin combined with biphasic calcium phosphate(experimental group); Other Names: Easy-graft/BCP
Active Comparator: autogenous bone graft; Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft	Other: Autogenous bone graft; Bone obtained from the same individual who receiving the graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height	the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.	six months postoperative.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2017
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Alveolar cleft -Platelet rich fibrin- calcium phosphate
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CEBD-CU-2017-09-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No