Dental ImplantNCT06037070
Impact of Biological Factors on Dental Implant
A study testing Platelet Rich Fibrin in people with Dental Implant, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
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: To investigate if bone reaction to PRF differ with different bone densities. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Platelet Rich Fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIraq
- Study dates
- 10 May 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
Who may be able to join
- 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 at least two successive implants.
- The exclusion criteria were as follows:
- Systemic disease or medication compromising bone and soft tissue healing.
Show all 9Show fewer
- Pathology in the edentulous region.
- Bruxism.
- Disease of the oral mucosa.
Who cannot join
None listed.
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: Impact of Biological Factors on Dental Implant Osseointegration
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Dental Implant
- Being tested
- Platelet Rich Fibrin
- Keywords
- Dental implants, PRF, CBCT, osseointegration, bone density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinBiological
PRF will be injected inside the hole that prepared to place dental implant
| Study group | Role | What they receive |
|---|---|---|
| group with PRF | Experimental | PRF placed inside the hole that prepared to place dental implant Receives: Biological: Platelet Rich Fibrin |
| control group | No intervention | with out and additive |
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.
Measured: Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Bone density
Determined using CBCT
Measured: before surgery, with the treatment plan preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start10 May 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 Dental ImplantStudies 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
- Model description
- Split-mouth trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 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
- Afya SD Al-radha, Ph. D, Principal investigator, College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037070
- Sponsor's protocol ID
- MUOSU-202104
- Status last verified
- Mar 2024
- First submitted
- 22 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
- Impact of Biological Factors on Dental Implant Osseointegration
- ClinicalTrials.gov ID
- NCT06037070
- Acronym / sponsor ID
- MUOSU-202104
- Conditions
- Dental Implant
- Keywords
- Dental implants, PRF, CBCT, osseointegration, bone density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 14 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 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:
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth trials
| Arm | Type | Receives |
|---|---|---|
| group with PRF | Experimental | Biological: Platelet Rich FibrinPRF placed inside the hole that prepared to place dental implant |
| control group | No intervention | –with out and additive |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 at least two successive implants.
- Systemic disease or medication compromising bone and soft tissue healing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Platelet Rich FibrinPRF will be injected inside the hole that prepared to place dental implant | Biological | group with PRF |
Primary outcome
osseointegration
Time frame: Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise.
Bone density
Time frame: before surgery, with the treatment plan preparation
Determined using CBCT
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
Afya SD Al-radha, Ph. D principal investigator
College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin in people with Dental Implant, 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?
The sponsor lists 9 inclusion and 0 exclusion criteria. 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 two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks). 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.