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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101954
• Other study ID #: PRF_GF_2019/2020
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Implants
• Tooth Extraction

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