Impact of Biological Factors on Dental Implant

NCT ID: NCT06037070

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth trials
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group with PRF

PRF placed inside the hole that prepared to place dental implant

Group Type EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

PRF will be injected inside the hole that prepared to place dental implant

control group

with out and additive

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet Rich Fibrin

PRF will be injected inside the hole that prepared to place dental implant

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Mustansiriyah University

OTHER

Sponsor Role lead

Responsible Party

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Afya Sahib Diab Al-radha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Afya SD Al-radha, Ph. D

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq

Locations

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Kadhimiya Teaching HospitalKadhimiya Educational Hospital

Baghdad, Alkadhmiya City, Iraq

Site Status

Countries

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Iraq

Central Contacts

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Assis. Prof. Dr. Afya SD Al-Radha, Ph.D

Role: CONTACT

07816883387 ext. 00964

Afya SD Al-radha, Ph.D

Role: CONTACT

07816883387 ext. 00964

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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MUOSU-202104

Identifier Type: -

Identifier Source: org_study_id

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