Osseointegrated Dental ImplantationPhase 2NCT02349620
Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible
A Phase 2 study testing PRF in people with Osseointegrated Dental Implantation, run by Reza Tabrizi at 1 site in Iran.
Trial summary
The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osseointegrated Dental Implantation
- What is being tested?
- PRF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to Oct 2015
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have 1 or 2 missing teeth in both side of posterior mandible
- adequate bone quantity and quality at the implant site
- the implant sites with at least 3 months of healing after extraction,
- patients well motivated for implant therapy and maintaining good oral hygiene
- the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.
- Patients who gave written informed consent
Who cannot join
- • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome
- infection around the implant site
- history of bruxism/parafunctional habits
- patients with history of any bleeding disorder or on anti-coagulant therapy.
- pregnant patients
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shiraz university of medical sciences
Shiraz, Fars
Reza Tabrizi, DMD, 989125850829, tabmed@gmail.com
Touba Karagah, DMD
About this study
Official title: Platelet-rich Factot in Implant Dentistry
The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.
Read the detailed description
Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \& distal side on standardized IOPA x-rays.
- Conditions
- Osseointegrated Dental Implantation
- Being tested
- PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFBiological
implant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF
| Study group | Role | What they receive |
|---|---|---|
| A:partialy edutolus patients | Active comparator | In this group surface treated implant with PRF will be inserted.Immediately after the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequency analysis (RFA), using the smart peg type 1, then stability will be measured every 2 weeks up to 3 months .Bone height will be measured in mesial and distal side immediately after placement and in months 3 and 6 with Intra Oral Peri Apical xray (IOPA x-ray) Receives: Biological: PRF |
| B: partialy edutolus patients | Placebo comparator | In this group implant with out PRF will be inserted.Immediately after the surgery the implant stability will be measured with the Osstell mentor to verify the resonance frequence analysis (RFA ), using the smartpeg type 1, then stability will be measured every 2 weeks up to 3 months. Bone height was measured in mesial and distal side immediately after placement and in months 3 and 6 with IOPA xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant loss
During the osseointegration, if the implant lose his stability and if the patient have pain, the implant will be removed and the implant will be considered lost
Measured: 6 months
Secondary outcomes (2)
ISQ analysis
Since the implant installation, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure
Measured: 3 months
bone height (mm)
Since the implant insertion , bone height was measured in mesial and distal side on standardized IOPA x-ray
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osseointegrated Dental ImplantationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reza Tabrizi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reza Tabrizi, Shiraz University of Medical Sciences
- Investigators
- Reza Tabrizi, DMD, Study chair, Shiraz University of Medical SciencesTouba karagah, DMD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349620
- Sponsor's protocol ID
- 123456
- Status last verified
- Jan 2015
- First submitted
- 5 Oct 2014
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Factot in Implant Dentistry
- ClinicalTrials.gov ID
- NCT02349620
- Acronym / sponsor ID
- 123456
- Conditions
- Osseointegrated Dental Implantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Reza TabriziUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 29 Jan 2015 (estimated)
- 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 main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.
Detailed description
Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \& distal side on standardized IOPA x-rays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A:partialy edutolus patients | Active comparator | Biological: PRFIn this group surface treated implant with PRF will be inserted.Immediately after the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequency analysis (RFA), using the smart peg type 1, then stability will be measured every 2 weeks up to 3 months .Bone height will be measured in mesial and distal side immediately after placement and in months 3 and 6 with Intra Oral Peri Apical xray (IOPA x-ray) |
| B: partialy edutolus patients | Placebo comparator | –In this group implant with out PRF will be inserted.Immediately after the surgery the implant stability will be measured with the Osstell mentor to verify the resonance frequence analysis (RFA ), using the smartpeg type 1, then stability will be measured every 2 weeks up to 3 months. Bone height was measured in mesial and distal side immediately after placement and in months 3 and 6 with IOPA xray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients who have 1 or 2 missing teeth in both side of posterior mandible
Key exclusion criteria (5 listed)
- • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome
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 |
|---|---|---|
| PRFimplant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF | Biological | A:partialy edutolus patients |
Primary outcome
implant loss
Time frame: 6 months
During the osseointegration, if the implant lose his stability and if the patient have pain, the implant will be removed and the implant will be considered lost
2 secondary outcomes
ISQ analysis
Time frame: 3 months
bone height (mm)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
Related trials for Osseointegrated Dental Implantation
Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
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.
Reza Tabrizi, DMD study chair
Shiraz University of Medical Sciences
Touba karagah, DMD principal investigator
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRF in people with Osseointegrated Dental Implantation, run by Reza Tabrizi at 1 site in Iran.
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 6 inclusion and 5 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 29 Jan 2015. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Reza Tabrizi, DMD (09125850829, Tabmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant loss (time frame: 6 months). 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 29 Jan 2015.