Dental ImplantNCT02190409
An Invivo Study to Compare the Stability of Dental Implants With or Without Platelet Rich Fibrin Application
A study testing Dental implant in people with Dental Implant, run by ELİF ONCU at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF application on implant osseointegration in the early phase of healing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to Dec 2012
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The absence of any lesions in the oral cavity, and sufficient residual bone volume to receive two or more adjacent implants of ≥3.5 mm in diameter and 11.0 mm in length, and extracted at least 6 months ago.
Who cannot join
- Insufficient bone volume
- Parafunctional habits
- Smoking more than 10 cigarettes per day
- Excessive consumption of alcohol
- Localized radiotherapy of the oral cavity
- Antitumor chemotherapy
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- Liver, blood, and kidney diseases
- Immunosuppression
- Current corticosteroid or bisphosphonate use
- Pregnancy
- Mucocutaneous diseases involving oral cavity
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,
Ankara
About this study
Official title: The Effect Of Platelet Rich Fibrin on Implant Stability
The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF application on implant osseointegration in the early phase of healing.
Read the detailed description
Objectives:Achieving accelerated implant osseointegration could provide immediate or early loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard tissue healing. Activated platelets in PRF release growth factors resulting in cellular proliferation, collagen synthesis and osteoid production. The aim of this study was to compare the stability of dental implants inserted with one-stage surgical protocol with or without PRF application.
Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket. Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis
- Conditions
- Dental Implant
- Being tested
- Dental implant
- Keywords
- Dental Implant,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
Also called The implant in this protocol, 3.5 mm width and 11 mm length) ANKYLOS C/X dental implants were used (Dentsply, Hanau, Germany
This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach
| Study group | Role | What they receive |
|---|---|---|
| Test, Control | Experimental | Test: Minimum two tapered implants (Ankylosis, Dentsply Friadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket Control: Other socket was selected as a control group (No Platelet Rich Fibrin used): In the control group no extra intervention used and the conventional procedure was done. Thus the readings of the experimental arm compared with this control. Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.
The stability of the implants were evaluated with the resonance frequency analysis (RFA) method. The measurements were carried out with Osstell ISQ (Implant Stability Quotient) (Osstell, Göteborg, Sweden) by connecting the transducer (smartpeg) to the implant. Two mesio-distal and bucco-lingual measurements were recorded and mean ISQ values were calculated. The resonance frequency measurements were repeated at first and fourth weeks.
Measured: Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
Secondary outcomes (1)
Evaluation of osseointegration in different types of bone
Evaluation early bone healing and compare stability of different bone type (based on the bone quality determined by the insertion torque value)
Measured: Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startDec 2011
- Primary completionJan 2012
- Study completionDec 2012
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELİF ONCU
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, ELİF ONCU, Necmettin Erbakan University
- Investigators
- ELİF ÖNCÜ, 1, Principal investigator, NECMETTİN ERBAKAN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190409
- Sponsor's protocol ID
- D-KA11/06
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Platelet Rich Fibrin on Implant Stability
- ClinicalTrials.gov ID
- NCT02190409
- Acronym / sponsor ID
- D-KA11/06
- Conditions
- Dental Implant
- Keywords
- Dental Implant,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ELİF ONCUUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jul 2014 (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 purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF application on implant osseointegration in the early phase of healing.
Detailed description
Objectives:Achieving accelerated implant osseointegration could provide immediate or early loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard tissue healing. Activated platelets in PRF release growth factors resulting in cellular proliferation, collagen synthesis and osteoid production. The aim of this study was to compare the stability of dental implants inserted with one-stage surgical protocol with or without PRF application.
Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket. Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test, Control | Experimental | Device: Dental implantTest: Minimum two tapered implants (Ankylosis, Dentsply Friadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket Control: Other socket was selected as a control group (No Platelet Rich Fibrin used): In the control group no extra intervention used and the conventional procedure was done. Thus the readings of the experimental arm compared with this control. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The absence of any lesions in the oral cavity, and sufficient residual bone volume to receive two or more adjacent implants of ≥3.5 mm in diameter and 11.0 mm in length, and extracted at least 6 months ago.
Key exclusion criteria (12 listed)
- Insufficient bone volume
- Parafunctional habits
- Smoking more than 10 cigarettes per day
- Excessive consumption of alcohol
- Localized radiotherapy of the oral cavity
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 |
|---|---|---|
| Dental implantAlso: The implant in this protocol, 3.5 mm width and 11 mm length) ANKYLOS C/X dental implants were used (Dentsply, Hanau, GermanyThis longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach | Device | Test, Control |
Primary outcome
Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.
Time frame: Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
The stability of the implants were evaluated with the resonance frequency analysis (RFA) method. The measurements were carried out with Osstell ISQ (Implant Stability Quotient) (Osstell, Göteborg, Sweden) by connecting the transducer (smartpeg) to the implant. Two mesio-distal and bucco-lingual measurements were recorded and mean ISQ values were calculated. The resonance frequency measurements were repeated at first and fourth weeks.
1 secondary outcome
Evaluation of osseointegration in different types of bone
Time frame: Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
ELİF ÖNCÜ, 1 principal investigator
NECMETTİN ERBAKAN 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 Dental implant in people with Dental Implant, run by ELİF ONCU at 1 site in Turkey (Türkiye).
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jul 2014. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period. (time frame: Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.). 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 15 Jul 2014.