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Clinical Trials/NCT06044246
NCT06044246
Not Yet Recruiting
N/A

Influence of Human Platelet Derivatives on Dental Implant Osseointegration

Al-Mustansiriyah University1 site in 1 country30 target enrollmentJune 20, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Platelet-Rich Fibrin
Sponsor
Al-Mustansiriyah University
Enrollment
30
Locations
1
Primary Endpoint
Osseointegration
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant.

Aims of the study:

  • To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant.
  • To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.

Detailed Description

Materials and methods: PRF will be obtained from a blood sample that is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is placed in a centrifuge at specially controlled rotations, temperature and time. The result is the separation of blood, basically from two by-products, including PRF. The PRF clot will be placed in specific box ( P.R.F -System; Surgident, CE ) to create a PRF membrane with specific thickness that will be placed on the bone around dental implant. Evaluation of the results * Alveolar bone width around dental implant will be measured. * Histological examination of the tissue that excised during dental implant uncover surgery. * Evaluate pain by visual analogue score (VAS). * Estimate the count of WBC and platelets in whole blood will be obtained from a laboratory results.

Registry
clinicaltrials.gov
Start Date
June 20, 2024
End Date
July 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Al-Mustansiriyah University
Responsible Party
Principal Investigator
Principal Investigator

Afya Sahib Diab Al-radha

Assistant Professor

Al-Mustansiriyah University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Osseointegration

Time Frame: Immediately after surgery, after 12 weeks (during uncover implant surgery)

Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise. \[Osstell ISQ device. (Stampgatan, Gteborg, Sweden)\] The Unit of measurement: ISQ (Implant Stability Quotient), which is a scale from 1 to 100.

Bone width

Time Frame: Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.

Measure the dimensional changes using special caliper (vernier) measurement tool, to evaluate the changes of bone width around dental implant. the Unit of measurement: millimeter (mm) (Bone and mucosa)

Study Sites (1)

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