Skip to main content
OpenTrials
Completed

NCT Number: NCT07164417

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

e-PRF membrane will be used with xenograft simultaneously with implant placement.

Other

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 The first 2-4 mL of platelet-poor plasma (PPP) is withdrawn and heated at 75 °C for 10 minutes to form albumin gel, then cooled for 1-2 minutes.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.

PRF membrane will be used with xenograft simultaneously with implant placement

Other

Peripheral blood is collected in 9-10 mL additive-free tubes and centrifuged horizontally at 700-2000 g for 8 minutes.

Primary outcomes

  1. Change in implant stability

    Time frame: baseline and 6 months

    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

Secondary outcomes

  1. change in pain scores

    Time frame: uo to 7 days

    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)

  2. Change in edema scores

    Time frame: up to 7 days

    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

  3. change in bone width gain

    Time frame: baseline and 6 months

    CBCT will be used

  4. change in bone density

    Time frame: baseline and 6 months

    CBCt will be used

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.