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

NCT03302429 | Completed

• 1 other identifier: CEBD-CU-2017-09-31
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Abnormality

Keywords

Alveolar cleft -Platelet rich fibrin- calcium phosphate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• bone volume

  six months postoperative.

• operation duration

  within 4 hours ( the actual number of hours will be determined intra-operative )

• hospital stay

  within 7 days

Study Arms (2)

PRF/ BCP

EXPERIMENTAL

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

Other: PRF/ BCP

autogenous bone graft

ACTIVE COMPARATOR

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

Other: Autogenous bone graft

Interventions

PRF/ BCP OTHER

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

Also known as: Easy-graft/BCP

PRF/ BCP

Autogenous bone graft OTHER

Bone obtained from the same individual who receiving the graft

autogenous bone graft

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from maxillary alveolar cleft
• Patients' age 8 years and older

You may not qualify if:

• Syndromic cases will be excluded
• Patients suffering from platelets disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 3311, Egypt

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resarcher

Model Details: 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)

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 5, 2017
• Study Start: November 19, 2017
• Primary Completion: January 27, 2023
• Study Completion: March 30, 2023
• Last Updated: November 4, 2024

Record last verified: 2017-10

Locations

EG (1)