Influence of Human Platelet Derivatives on Dental Implant

NCT ID: NCT06044246

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Platelet-Rich Fibrin Dental Implantation Bone Substitute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental group

Placing dental implant with PRF membrane treatment alone or combined with bone substitute.

Group Type EXPERIMENTAL

PRF membrane

Intervention Type BIOLOGICAL

Placing implant with PRF membrane treatment

control group

Placing dental implant

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRF membrane

Placing implant with PRF membrane treatment

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 dental implant.

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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Assis. Prof. Dr. Afya SD Al-radha

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry, Mustansiriyah University.

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

Assis. Prof. Dr. Afya SD Al-radha

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-202103

Identifier Type: -

Identifier Source: org_study_id

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