Influence of Human Platelet Derivatives on Dental Implant

Study Overview
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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.

Official Title
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Influence of Human Platelet Derivatives on Dental Implant Osseointegration

Conditions
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Platelet-Rich Fibrin, Dental Implantation, Bone Substitute

Intervention / Treatment
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* Biological: PRF membrane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osseointegration | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRF, Dental implant, membrane, osseointegration