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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05101954
Other study ID # PRF_GF_2019/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date August 17, 2021

Study information

Verified date October 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Bone density The Patients will be asked to do CBCT immediately after surgery and after 3 months immediately, after 3 months
Primary Change in bone formation Amount of bone formed buccal and lingual to the implant will be assessed using CBCT immediately, after 3 months
Primary Marginal bone loss it will be assessed using CBCT after 3 months
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