Study Results
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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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2024-05-10
2025-07-30
Brief Summary
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The main questions it aims to answer are:
* To investigate if bone reaction to PRF differ with different bone densities.
* To study the effect of PRF on dental implant healing and to assess its effectiveness in accelerating osseointegration.
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group with PRF
PRF placed inside the hole that prepared to place dental implant
Platelet Rich Fibrin
PRF will be injected inside the hole that prepared to place dental implant
control group
with out and additive
No interventions assigned to this group
Interventions
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Platelet Rich Fibrin
PRF will be injected inside the hole that prepared to place dental implant
Eligibility Criteria
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Inclusion Criteria
* No medical history of any systemic diseases that affect the bone metabolism.
* Did not receive any systemic drugs.
* Has edentulous area that needs at least two successive implants.
Exclusion Criteria
* Pathology in the edentulous region.
* Bruxism.
* Disease of the oral mucosa.
20 Years
ALL
Yes
Sponsors
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Al-Mustansiriyah University
OTHER
Responsible Party
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Afya Sahib Diab Al-radha
Assistant Professor
Principal Investigators
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Afya SD Al-radha, Ph. D
Role: PRINCIPAL_INVESTIGATOR
College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq
Locations
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Kadhimiya Teaching HospitalKadhimiya Educational Hospital
Baghdad, Alkadhmiya City, Iraq
Countries
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Central Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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MUOSU-202104
Identifier Type: -
Identifier Source: org_study_id
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