Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

Not Applicable

Completed

• Conditions: Xenograft; Symphysis Onlay Bone Graft; Horizontal Alveolar Ridge Augmentation; Esthetic Zone; Platelet Rich Fibrin
• Interventions: Other: Xenograft; Other: Injectable Platelet Rich Fibrin

• Registration Number: NCT06388837
• Lead Sponsor: October 6 University

Brief Summary

The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft

Detailed Description

Alveolar bone resorption is one of complications post-extraction complications where there is a reduction in the dimensions and quality of the alveolar bone. Alveolar bone resorption is known to occur over time, but resorption in the first few months of tooth extraction is known to be very significant.

The ideal bone graft material should have osteoconductive, osteogenic, and osteoinductive properties and mechanical stability and be free from disease. Osteoconductive is a physical property of a material that provides a framework for the growth of blood vessels and osteoprogenitor cells in bone formation. Osteoinductiveness is the ability to stimulate stem cells to differentiate in mature cells through stimulation by local growth factors. Osteogenicity is the bone growth factors in bone grafts.

Growth factors from PRF such as platelet-derived growth factor (PDGF), transforming growth factor (TGF), and insulin growth factor (IGF) are known to play a significant role in healing and bone regeneration to prevent excessive alveolar resorption after tooth extraction.

Study Timeline

• Study Start: 2021-02-20
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age from 20 to 40 years.
• Both sexes.
• Patients suffering from horizontal alveolar ridge deficiency in anterior maxilla with labio-palatal dimensions less than 4 mm.
• Patients with adequate vertical ridge height compared to the neighboring alveolar bone.
• Patients with good oral hygiene and adjacent teeth bounding the empty span (span ranged from 1 to 4 missing teeth), should have healthy periodontium, intact or properly restored.
• Patients were apparently free from any systemic disease that may affect normal healing process of bone.

Exclusion Criteria

• Patients suffering from any systemic diseases were excluded from the study.
• Poor oral hygiene and motivation.
• General contraindications to implant surgery.
• Uncontrolled diabetes.
• Irradiation, chemotherapy, or immunosuppressive therapy over the past 5 years.
• Active periodontitis.
• Psychiatric problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (Symphysis Onlay bone graft mixed with Xenograft)	Xenograft	Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).
Group I (Symphysis Onlay bone graft with injectable platelet rich fibrin placement)	Injectable Platelet Rich Fibrin	Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

Primary Outcome Measures

Name	Time	Method
Alveolar ridge width	6 months postoperative	Cone beam computed tomography (CBCT) was done to all patients to measure alveolar ridge width at the following intervals: pre-operative and 6 months postoperative.

Secondary Outcome Measures

Name	Time	Method
Bone density	6 months postoperative	Cone beam computed tomography (CBCT) was done to all patients to measure bone density at the following intervals: pre-operative and 6 months postoperative.

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, Egypt