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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03302429
Enrollment
18
Registered
2017-10-05
Start date
2017-11-19
Completion date
2023-03-30
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Ridge Abnormality

Keywords

Alveolar cleft -Platelet rich fibrin- calcium phosphate

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

Interventions

OTHERPRF/ BCP

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

Bone obtained from the same individual who receiving the graft

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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)

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
bone heightsix 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

MeasureTime frameDescription
bone volumesix 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 durationwithin 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 staywithin 7 daysNumber of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026