Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants

A Comparative Study Between the Effect of Platelet-rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants (a Randomized Clinical Trial)

This study will involve 14 patients with mandibular premolars indicated for extraction and immediate replacement. The patients will be randomly allocated into two groups and each patient will receive one implant. In Group A, a CGF membrane will be laid in the implant cavity. While in Group B, a PRF membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.

Resonance frequency measurement will be done using the OSTELL device intraoperatively, at the 1st week and after 3 months. Cone-beam computed tomography will be done preoperatively, immediately following surgery, and after 3 months

Study Overview

• Status: Completed
• Conditions: Dental Implants; Tooth Extraction
• Intervention / Treatment: Procedure: Concentrated Growth Factors (CGF); Procedure: Platelet-Rich Fibrin (PRF)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cooperative patients with good oral hygiene.
• Patients having a history of mandibular premolars indicated for extraction and immediate replacement.

Exclusion Criteria:

• Heavy smokers.
• Parafunctional occlusal habits.
• Uncontrolled diabetes.
• History of chemotherapy or radiotherapy.
• Hematological disorders that prevent either implantation or centrifugation.
• Pregnancy.
• The nee¬d for additional augmentation or previous augmentation of the same region.
• Chronic periapical pathology

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Procedure: Concentrated Growth Factors (CGF); Concentrated Growth Factors membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.
Active Comparator: Group B	Procedure: Platelet-Rich Fibrin (PRF); Platelet-Rich Fibrin (PRF) membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	Osstell instrument (Integration Diagnostics, Goteborg, Sweden) with Smartpeg™ (Integration Diagnostics, Goteborg, Sweden), a transducer suitable for implants will be used to assess stability of implants by RFA. ISQ (implant stability quotient) will be obtained from the measurement results. During measurement, the Smartpeg™ will be placed over the location of implant prosthesis and the Osstell probe will be approximated to it from the buccal, palatal, mesial and distal aspects of the implant giving four ISQ values. A mean ISQ for each implant is then calculated by averaging the four values. The ISQ values of the implants will be measured during the operation, at the first week and three months after the operation.	immediately, at 1 week, at 3 months
Change in Bone density	The Patients will be asked to do CBCT immediately after surgery and after 3 months	immediately, after 3 months
Change in bone formation	Amount of bone formed buccal and lingual to the implant will be assessed using CBCT	immediately, after 3 months
Marginal bone loss	it will be assessed using CBCT	after 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 17, 2021
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: PRF_GF_2019/2020

Drug and device information, study documents

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