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

Primary Purpose

Alveolar Ridge Abnormality

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRF/ BCP
Autogenous bone graft
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Ridge Abnormality focused on measuring Alveolar cleft -Platelet rich fibrin- calcium phosphate

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF/ BCP

autogenous bone graft

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
hospital stay
Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge

Full Information

First Posted
October 1, 2017
Last Updated
October 4, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03302429
Brief Title
Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Ridge Abnormality
Keywords
Alveolar cleft -Platelet rich fibrin- calcium phosphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRF/ BCP
Arm Type
Experimental
Arm Description
Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF
Arm Title
autogenous bone graft
Arm Type
Active Comparator
Arm Description
Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft
Intervention Type
Other
Intervention Name(s)
PRF/ BCP
Other Intervention Name(s)
Easy-graft/BCP
Intervention Description
Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)
Intervention Type
Other
Intervention Name(s)
Autogenous bone graft
Intervention Description
Bone obtained from the same individual who receiving the graft
Primary Outcome Measure Information:
Title
bone height
Description
the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.
Time Frame
six months postoperative.
Secondary Outcome Measure Information:
Title
bone volume
Description
V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices
Time Frame
six months postoperative.
Title
operation duration
Description
It is the time elapsed between using the scalable for incision and the last stitch. It will be measured by watch in hours.
Time Frame
within 4 hours ( the actual number of hours will be determined intra-operative )
Title
hospital stay
Description
Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge
Time Frame
within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hebatallah G Samra El-Shamy
Phone
+201284235900
Email
hebatallah_samra@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan A Osman, lecturer
Phone
+201001545449
Email
hassan_ao@yahoo.com
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
3311
Country
Egypt

12. IPD Sharing Statement

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

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