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Clinical Trials/NCT05101954
NCT05101954
Completed
Not Applicable

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

Hams Hamed Abdelrahman1 site in 1 country14 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Extraction
Sponsor
Hams Hamed Abdelrahman
Enrollment
14
Locations
1
Primary Endpoint
Marginal bone loss
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 17, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hams Hamed Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Marginal bone loss

Time Frame: after 3 months

it will be assessed using CBCT

Change in Bone density

Time Frame: immediately, after 3 months

The Patients will be asked to do CBCT immediately after surgery and after 3 months

Change in bone formation

Time Frame: immediately, after 3 months

Amount of bone formed buccal and lingual to the implant will be assessed using CBCT

Change in implant stability

Time Frame: immediately, at 1 week, at 3 months

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.

Study Sites (1)

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