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

NCT05101954 | Completed

• 1 other identifier: PRF_GF_2019/2020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Extraction; Dental Implants

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Procedure: Concentrated Growth Factors (CGF)

Group B

ACTIVE COMPARATOR

Procedure: Platelet-Rich Fibrin (PRF)

Interventions

Concentrated Growth Factors (CGF) PROCEDURE

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.

Group A

Platelet-Rich Fibrin (PRF) PROCEDURE

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.

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: October 1, 2020
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

EG (1)