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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Placing dental implant with PRF membrane treatment alone or combined with bone substitute. |
|
| control group | No Intervention | Placing dental implant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF membrane | Biological | Placing implant with PRF membrane treatment |
|
| 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. |
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IInclusion criteria
The exclusion criteria were as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assis. Prof. Dr. Afya SD Al-Radha, Ph.D | Contact | 07816883387 | 00964 | drafya_diab@uomustansiriyah.edu.iq |
| Assis. Prof. Dr. Afya SD Al-radha | Contact | 07816883387 | 00964 | drafya_diab@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Assis. Prof. Dr. Afya SD Al-radha | College of Dentistry, Mustansiriyah University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kadhimiya Teaching HospitalKadhimiya Educational Hospital | Baghdad | Alkadhmiya City | 60 St | Iraq |
all IPD that underlie results in a publication
following publication. No end date.
Anyone who wishes to access the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2023 | Sep 8, 2023 | ICF_000.pdf |
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