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Completed

NCT Number: NCT05101954

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

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

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Key information

Conditions

Tooth Extraction Dental Implants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. Marginal bone loss

    Time frame: after 3 months

    it will be assessed using CBCT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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