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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group with PRF | Experimental | PRF placed inside the hole that prepared to place dental implant |
|
| control group | No Intervention | with out and additive |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Fibrin | Biological | PRF will be injected inside the hole that prepared to place dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| osseointegration | Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise. | Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks |
| Bone density | Determined using CBCT | before surgery, with the treatment plan preparation |
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Inclusion 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 |
| Afya SD Al-radha, Ph.D | Contact | 07816883387 | 00964 | drafya_diab@uomustansiriyah.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Afya SD Al-radha, Ph. D | College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq | 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
after publication of the research, 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 6, 2023 | Sep 7, 2023 | ICF_000.pdf |
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Split-mouth trials
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