Platelet-Rich FibrinNCT06044246
Influence of Human Platelet Derivatives on Dental Implant
A study testing PRF membrane in people with Platelet-Rich Fibrin and Dental Implantation, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet-Rich Fibrin, Dental Implantation, Bone Substitute
- What is being tested?
- PRF membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 20 Jun 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Assis. Prof. Dr. Afya SD Al-Radha, Ph.D contact
Iraq1 site
Kadhimiya Teaching HospitalKadhimiya Educational Hospital
Baghdad, Alkadhmiya City, 60 St
About this study
Official title: Influence of Human Platelet Derivatives on Dental Implant Osseointegration
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.
Read the 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.
- Conditions
- Platelet-Rich Fibrin, Dental Implantation, Bone Substitute
- Being tested
- PRF membrane
- Keywords
- Dental implant, PRF, membrane, osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF membraneBiological
Placing implant with PRF membrane treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Placing dental implant with PRF membrane treatment alone or combined with bone substitute. Receives: Biological: PRF membrane |
| control group | No intervention | Placing dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Jun 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich FibrinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afya Sahib Diab Al-radha, Al-Mustansiriyah University
- Investigators
- Assis. Prof. Dr. Afya SD Al-radha, Principal investigator, College of Dentistry, Mustansiriyah University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044246
- Sponsor's protocol ID
- MUOSU-202103
- Status last verified
- Mar 2024
- First submitted
- 24 Nov 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Human Platelet Derivatives on Dental Implant Osseointegration
- ClinicalTrials.gov ID
- NCT06044246
- Acronym / sponsor ID
- MUOSU-202103
- Conditions
- Platelet-Rich Fibrin, Dental Implantation, Bone Substitute
- Keywords
- Dental implant, PRF, membrane, osseointegration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: PRF membranePlacing dental implant with PRF membrane treatment alone or combined with bone substitute. |
| control group | No intervention | –Placing dental implant |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRF membranePlacing implant with PRF membrane treatment | Biological | experimental group |
Primary outcome
Osseointegration
Time frame: Immediately 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 width
Time frame: Baseline (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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assis. Prof. Dr. Afya SD Al-Radha, Ph.D contact
Assis. Prof. Dr. Afya SD Al-radha principal investigator
College of Dentistry, Mustansiriyah University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF membrane in people with Platelet-Rich Fibrin and Dental Implantation, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assis. Prof. Dr. Afya SD Al-Radha, Ph.D (07816883387 ext. 00964, drafya_diab@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseointegration (time frame: Immediately after surgery, after 12 weeks (during uncover implant surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.