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

NCT ID: NCT06388837

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2023-03-01

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.

Conditions

Symphysis Onlay Bone Graft; Platelet Rich Fibrin; Xenograft; Horizontal Alveolar Ridge Augmentation; Esthetic Zone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group I (Symphysis Onlay bone graft with injectable platelet rich fibrin placement)

Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

Group Type: EXPERIMENTAL

Injectable Platelet Rich Fibrin

Intervention Type: OTHER

Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

Group II (Symphysis Onlay bone graft mixed with Xenograft)

Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

Group Type: EXPERIMENTAL

Xenograft

Intervention Type: OTHER

Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

Interventions

Injectable Platelet Rich Fibrin

Patients underwent mandibular symphysis Onlay bone graft mixed with injectable platelet rich fibrin (I-PRF) placement.

Intervention Type: OTHER

Xenograft

Patients underwent mandibular symphysis Onlay bone graft mixed with Xenograft (InterOss® Anorganic Cancellous Granules).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Amany Ahmed Mohamed Alaraby

Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

October 6 University

Giza, , Egypt

Countries

Egypt

Other Identifiers

RECO6U/20- 2021

Identifier Type: -

Identifier Source: org_study_id