Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting

Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting With Simultaneous Implant Placement

Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.

Study Overview

• Status: Not yet recruiting
• Conditions: Ridge Splitting
• Intervention / Treatment: Procedure: ridge splitting with the use of allograft and pericardium membrane; Procedure: ridge splitting with the use of extended platelet rich fibrin

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: faisal alshammri; Phone Number: 0020 1555250898; Email: fasialshammry@std.mans.edu.eg

Study Locations

• Egypt
  • Mansoura, Egypt, Egypt
    • Mansoura University
    • Contact: faisal alshammri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient age 18 years old and older.
• Patient's cooperation, motivation and good oral hygiene.
• Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
• Absence of undercuts in buccal aspect of the ridge.
• Favorable occlusion and no parafunctional habits.
• Patients able to comply with the required recall visits.
• No gender preface in selection of the patients.
• Acceptable inter-arch space for the future prosthesis.

Exclusion Criteria:

• Any pathological condition at the site of surgery.
• Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
• Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
• Heavy smoking and alcoholism.
• Parafunctional habits such as bruxism and clenching.
• Signs of acute infection or pus discharge.
• Untreated periodontal disease or bad oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ridge splitting with allograft and pericardium membrane	Procedure: ridge splitting with the use of allograft and pericardium membrane; ridge splitting with the use of allograft and pericardium membrane
Experimental: ridge splitting with extended platelet rich fibrin	Procedure: ridge splitting with the use of extended platelet rich fibrin; ridge splitting with the use of extended platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant stability	the stability of the implants will be evaluated by RFA with the Osstell Mentor device	9 months
alveolar ridge width	alveolar ridge width will be measured preoperative, immediate postoperative and after 9 months	9 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2024
• Primary Completion (Estimated): April 10, 2025
• Study Completion (Estimated): October 10, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A0302024OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No