Impact of Biological Factors on Dental Implant

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

Impact of Biological Factors on Dental Implant Osseointegration

The goal of this randomized controlled trial is to compare the response of different bone densities to treatment with Platelet Rich Fibrin (PRF) in patients who need treatment with dental implant.

The main questions it aims to answer are:

  • To investigate if bone reaction to PRF differ with different bone densities.
  • To study the effect of PRF on dental implant healing and to assess its effectiveness in accelerating osseointegration.

Participants who need treatment with dental implant will be planned to include in this study and will be asked if they are willing to participate in this study voluntarily.

All the participants will be given an information sheet and a consent form which provides simple description about the present study and its importance to insure voluntary participation. The patients will be aware that they are completely free to withdraw from the research any time during the research time.

Platelet Rich Fibrin will be injected inside the hole that prepared to place dental implant in. Bone density will be evaluated, degree of osseointegration will be monitored.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Materials and methods:

Two implants will be implanted at the same time, one will have PRF that will be injected inside the hole that prepared to place dental implant in [PRF is obtained from a blood sample 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 other implant will not receive any treatment (the control one).

Evaluation of the results

  • Evaluation of bone density in implant site will be determined using CBCT [ the same CBCT that have been used for planning dental implant treatment].

    ***[In dental implant treatment it is mandatory to perform CBCT for each patient, to ensure the accuracy of dental implant size and position, and to ensure there will be no damage to any vital structure during surgery (e.g. inferior dental nerve, maxillary sinus, …etc)].

  • Evaluation of the degree of osseointegration will be performed using Osstell devise. [Osstell is a tool uses Resonance Frequency Analysis (RFA) that measures the frequency with which a device vibrates]. Measurement will be conducted at implant placement for a baseline reading and after 2weeks, 4weeks, 8 weeks, 10 weeks, 12 weeks.
  • Evaluate pain by visual analogue score (VAS).
  • Estimate of the complete blood picture, vit D, Ca and K will obtained from laboratory results.

Study Type

Interventional

Enrollment (Estimated)

10

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

Inclusion 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 at least two successive implants.

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: group with PRF
PRF placed inside the hole that prepared to place dental implant
Biological: Platelet Rich Fibrin
PRF will be injected inside the hole that prepared to place dental implant
No Intervention: control group
with out and additive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
osseointegration
Time Frame: Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise.
Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Bone density
Time Frame: before surgery, with the treatment plan preparation
Determined using CBCT
before surgery, with the treatment plan preparation

Collaborators and Investigators

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

Sponsor

Al-Mustansiriyah University

Investigators

  • Principal Investigator: Afya SD Al-radha, Ph. D, College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq

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)

May 10, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 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-202104

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

after publication of the research, 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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