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Clinical Trials/NCT06037070
NCT06037070
Not yet recruiting
Not Applicable

Impact of Biological Factors on Dental Implant Osseointegration

Al-Mustansiriyah University1 site in 1 country10 target enrollmentMay 10, 2024
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Al-Mustansiriyah University
Enrollment
10
Locations
1
Primary Endpoint
Bone density
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 10, 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

Bone density

Time Frame: before surgery, with the treatment plan preparation

Determined using CBCT

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.

Study Sites (1)

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