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

NCT06388837 | Completed

• 1 other identifier: RECO6U/20- 2021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge width

  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.

  6 months postoperative

Secondary Outcomes (1)

• Bone density

  6 months postoperative

Study Arms (2)

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

EXPERIMENTAL

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

Other: Injectable Platelet Rich Fibrin

Group II (Symphysis Onlay bone graft mixed with Xenograft)

EXPERIMENTAL

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

Other: Xenograft

Interventions

Injectable Platelet Rich Fibrin OTHER

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

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

Xenograft OTHER

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

Group II (Symphysis Onlay bone graft mixed with Xenograft)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, 12511, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: February 20, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)