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Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting

NCT04693741 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-05

No results posted yet for this study

Summary

this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.

Conditions

  • Alveolar Cleft

Interventions

PROCEDURE

secondary alveolar bone graft

Under general anesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will be injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will be made on both sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will be dissected. Next, the bone particles will be implanted into the bone defect. Then, The cleft site will be closed without tension by the advancement of the gingival flaps.

PROCEDURE

Harvesting of the autogenous bone graft

Under general anaesthesia ,the soft tissue in the superior iliac crest will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. The cancellous bone will harvested with an osteotome and then cut into small bone granules.

PROCEDURE

Preparation of PRP

10 ml of blood will be collected in vacuum tubes without anticoagulants which are then immediately centrifuged at a rate of 3000 rpm for 10 min. After centrifugation, the resultant product consists of three layers. The topmost layer consisting of acellular PPP (platelet poor plasma), PRF clot in the middle and RBCs at the bottom of the test tube. The attached red blood cells scraped off from it and discarded. The discarded PRF is then mixed with xenograft and placed inside the alveolar defect.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed Elshazly, professor · Assiut University

  • Awny asklany, doctor · Assiut University

  • mohammed nahed attia, doctor · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-11-30
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693741 on ClinicalTrials.gov