Influence of Human Platelet Derivatives on Dental Implant

March 15, 2024 updated by: Afya Sahib Diab Al-radha, Al-Mustansiriyah University

Influence of Human Platelet Derivatives on Dental Implant Osseointegration

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Alkadhmiya City
      • Baghdad, Alkadhmiya City, Iraq, 60 St
        • Kadhimiya Teaching HospitalKadhimiya Educational Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

IInclusion criteria

  • Non- smoker.
  • No medical history of any systemic diseases that affect the bone metabolism.
  • Did not receive any systemic drugs.
  • Has edentulous area that needs dental implant.

The exclusion criteria were as follows:

  • Systemic disease or medication compromising bone and soft tissue healing.
  • Pathology in the edentulous region.
  • Bruxism.
  • Disease of the oral mucosa.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Placing dental implant with PRF membrane treatment alone or combined with bone substitute.
Biological: PRF membrane
Placing implant with PRF membrane treatment
No Intervention: control group
Placing dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after surgery, after 12 weeks (during uncover implant surgery)
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)
Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustansiriyah University

Investigators

  • Principal Investigator: Assis. Prof. Dr. Afya SD Al-radha, College of Dentistry, Mustansiriyah University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUOSU-202103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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