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Completed

NCT Number: NCT03302429

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

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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Key information

Conditions

Alveolar Ridge Abnormality

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 3311, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRF/ BCP

Other

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

Other names: Easy-graft/BCP

Autogenous bone graft

Other

Bone obtained from the same individual who receiving the graft

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2017
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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