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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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ClinicalTrials.gov Identifier: NCT03302429
Recruitment Status : Not yet recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hebatallah G Samra El-Shamy, 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.

Condition or disease Intervention/treatment Phase
Alveolar Ridge Abnormality Other: PRF/ BCP Other: Autogenous bone graft Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. bone height [ Time Frame: 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 :
  1. bone volume [ Time Frame: 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


  2. operation duration [ Time Frame: 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.


  3. hospital stay [ Time Frame: within 7 days ]
    Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302429


Contacts
Contact: Hebatallah G Samra El-Shamy +201284235900 hebatallah_samra@yahoo.com
Contact: Hassan A Osman, lecturer +201001545449 hassan_ao@yahoo.com

Locations
Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 3311
Sponsors and Collaborators
Cairo University

Responsible Party: Hebatallah G Samra El-Shamy, resarcher, Cairo University
ClinicalTrials.gov Identifier: NCT03302429     History of Changes
Other Study ID Numbers: CEBD-CU-2017-09-31
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

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

Keywords provided by Hebatallah G Samra El-Shamy, Cairo University:
Alveolar cleft -Platelet rich fibrin- calcium phosphate

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs