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Influence of Human Platelet Derivatives on Dental Implant

Not Applicable
Not yet recruiting
Conditions
Platelet-Rich Fibrin
Dental Implantation
Bone Substitute
Interventions
Biological: PRF membrane
Registration Number
NCT06044246
Lead Sponsor
Al-Mustansiriyah University
Brief Summary

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

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental groupPRF membranePlacing dental implant with PRF membrane treatment alone or combined with bone substitute.
Primary Outcome Measures
NameTimeMethod
OsseointegrationImmediately after surgery, after 12 weeks (during uncover implant surgery)

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.

Bone widthBaseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.

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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kadhimiya Teaching HospitalKadhimiya Educational Hospital

🇮🇶

Baghdad, Alkadhmiya City, Iraq

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