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

Study Overview
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Brief Summary
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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

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

Conditions
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Tooth Extraction, Dental Implants

Intervention / Treatment
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* Procedure: Concentrated Growth Factors (CGF)
* Procedure: Platelet-Rich Fibrin (PRF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Procedure: Concentrated Growth Factors (CGF)<br>* 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.<br>|
| Active Comparator: Group B<br> | Procedure: Platelet-Rich Fibrin (PRF)<br>* 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.<br>|

What is the study measuring?
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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 |