Two Types of PRF Membranes in Management of Dehiscence Defect in Posterior Mandible

Comparing Two Types of PRF Membranes in Management of Dehiscence Defect With Simultaneous Implant Placement in Posterior Mandible (Randomized Controlled Clinical Trial)

Background: Placement of implants in an atrophic posterior ridge is a challenge for so many clinicians. The success of dental implants depends on the volume of alveolar bone available to provide stability. Bone grafting using xenograft with PRF and e-PRF as a membrane has shown promising results in both bone healing and defect reconstruction. Aim of the study: to evaluate the effect of Platelet-rich fibrin (PRF) and Extended Platelet-rich fibrin (e-PRF) as a membrane with xenograft to increase the width of ridge in posterior mandible with simultaneous implant placement.

Study Overview

• Status: Completed
• Conditions: Atrophic Mandible
• Intervention / Treatment: Other: PRF membrane will be used with xenograft simultaneously with implant placement; Other: e-PRF membrane will be used with xenograft simultaneously with implant placement.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with one or more missing posterior mandibular teeth.
• Patient with atrophic posterior mandible with residual ridge width in the range of 4 to 6mm.
• Patient with good oral hygiene and acceptable inter-arch space less than or equal to the restoration

Exclusion Criteria:

• The patient underwent alveolar ridge reconstruction in the same area.
• Patients with immune diseases, uncontrolled hypertension, and uncontrolled diabetes.
• Patient with any pathological condition at the site of surgery.
• Heavy smoker, alcohol abuse, parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRF	Other: PRF membrane will be used with xenograft simultaneously with implant placement; Peripheral blood is collected in 9-10 mL additive-free tubes and centrifuged horizontally at 700-2000 g for 8 minutes.
Experimental: e-PRF	Other: e-PRF membrane will be used with xenograft simultaneously with implant placement.; Peripheral blood is collected in plain tubes and centrifuged (700-2000 g, 8 min) to separate plasma from red cells. The first 2-4 mL of platelet-poor plasma (PPP) is withdrawn and heated at 75 °C for 10 minutes to form albumin gel, then cooled for 1-2 minutes. Meanwhile, the remaining blood fractions (buffy coat, liquid PRF, red cells) are kept cooled to prevent premature clotting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	Osstell device will be used to measure the implant stability, primary stability Just after implant placement, and secondary stability 6 months from the time of implant placement. The measured values will be recorded in ISQ from 1 to 100, Implant stability is directly proportional to ISQ value	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain scores	Visual Analogue Scale (VAS) will be used to assess pain for 7 days postoperatively using a 10-point (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)	uo to 7 days
Change in edema scores	Assessment of edema will be done immediately, post-operative on the 2nd, 3rd, and 7th days as follows: no inflammation= none intraoral swelling confined to the surgical field = mild extraoral swelling in the surgical zone= moderate extraoral swelling spreading beyond the surgical zone= intense	up to 7 days
change in bone width gain	CBCT will be used	baseline and 6 months
change in bone density	CBCt will be used	baseline and 6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: September 4, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0936-06/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No