Dental Implant Failure NosNCT03501199
Comparison of Different Materials Contribution to Implants Stability
A study testing platelet-rich fibrin placement, xenogenic graft placement and no extra material in people with Dental Implant Failure Nos, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure Nos
- What is being tested?
- platelet-rich fibrin placement, xenogenic graft placement and no extra material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 4 Mar 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- medically healthy,
- only one maxillary aesthetic region(incisors or premolars) tooth which has two adjacent teeth is indicated for extraction.
- intact buccal socket walls
- the gap between buccal socket wall to implant sholder at least 2 mm.
Who cannot join
- relevant tooth has more than one root,
- smoking,
- alcohol abuse,
- pregnancy,
- immune-suppressive patients,
- any systemic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of dentistry
Konya
About this study
Official title: Comparison of Different Materials Contribution to Immediate Implants Stability With Resonance Frequency Analysis
The investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. The resonance frequency analysis device(Osstell) will be used to measure primary and secondary stabilization. Then the investigators will evaluate each materials' contribution to stability.
Pre-op and 9th month Post-op CBCTs will evaluate about bone loss in mesial-distal and horizontal dimensions.
- Conditions
- Dental Implant Failure Nos
- Being tested
- platelet-rich fibrin placement, xenogenic graft placement, no extra material, tooth extraction, immediate implant placement
- Keywords
- immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich fibrin placementOther
filling the buccal gap with platelet-rich fibrin after immediate dental implant placement
xenogenic graft placementOther
filling the buccal gap with xenogenic graft after immediate dental implant placement
no extra materialOther
filling the buccal gap with no material after immediate dental implant placement
tooth extractionProcedure or surgery
extraction of tooth which is unrestorable
immediate implant placementProcedure or surgery
putting dental implant into a socket which has been prepared with compatible drills
collagen membran placementOther
placing collagen membran on extraction socket after dental implant placement to cover all
raising flapProcedure or surgery
raising the buccal flap with two vertical incision to cover extraction socket for primary closure
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Experimental | PRF is will be used in immediate dental implant placement. Receives: Other: platelet-rich fibrin placement; Procedure: tooth extraction; Procedure: immediate implant placement; Other: collagen membran placement; Procedure: raising flap |
| Graft Group | Experimental | The xenogenic graft is will be used in immediate dental implant placement. Receives: Other: xenogenic graft placement; Procedure: tooth extraction; Procedure: immediate implant placement; Other: collagen membran placement; Procedure: raising flap |
| Control Group | Experimental | No extra material is will be used in immediate dental implant placement. Receives: Other: no extra material; Procedure: tooth extraction; Procedure: immediate implant placement; Other: collagen membran placement; Procedure: raising flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primer Stabilization-Resonance Frequency Analysis
initial measurement after placement by Osstell device
Measured: at 0 day
Secondary outcomes (2)
Seconder Stabilization-Resonance Frequency Analysis
secondary measurement after placement by Osstell device
Measured: 120th day
Mesial-Distal and Horizontal Bone Loss
The alveolar bone loss between first day to 9th month
Measured: 9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Mar 2018
- Primary completion31 May 2018
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Failure NosStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Gürses, Necmettin Erbakan University
- Investigators
- Alparslan Esen, Study chair, ConsultantGökhan Gürses, Study director, Care Provider
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501199
- Sponsor's protocol ID
- NecmettinEU-Dentistry
- Status last verified
- Dec 2018
- First submitted
- 23 Mar 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Materials Contribution to Immediate Implants Stability With Resonance Frequency Analysis
- ClinicalTrials.gov ID
- NCT03501199
- Acronym / sponsor ID
- NecmettinEU-Dentistry
- Conditions
- Dental Implant Failure Nos
- Keywords
- immediate implant placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 18 Apr 2018 (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 investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. The resonance frequency analysis device(Osstell) will be used to measure primary and secondary stabilization. Then the investigators will evaluate each materials' contribution to stability.
Pre-op and 9th month Post-op CBCTs will evaluate about bone loss in mesial-distal and horizontal dimensions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Other: platelet-rich fibrin placement, Procedure: tooth extraction, Procedure: immediate implant placement, Other: collagen membran placement, Procedure: raising flapPRF is will be used in immediate dental implant placement. |
| Graft Group | Experimental | Other: xenogenic graft placement, Procedure: tooth extraction, Procedure: immediate implant placement, Other: collagen membran placement, Procedure: raising flapThe xenogenic graft is will be used in immediate dental implant placement. |
| Control Group | Experimental | Other: no extra material, Procedure: tooth extraction, Procedure: immediate implant placement, Other: collagen membran placement, Procedure: raising flapNo extra material is will be used in immediate dental implant placement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- medically healthy,
- only one maxillary aesthetic region(incisors or premolars) tooth which has two adjacent teeth is indicated for extraction.
- intact buccal socket walls
- the gap between buccal socket wall to implant sholder at least 2 mm.
Key exclusion criteria (6 listed)
- relevant tooth has more than one root,
- smoking,
- alcohol abuse,
- pregnancy,
- immune-suppressive patients,
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 fibrin placementfilling the buccal gap with platelet-rich fibrin after immediate dental implant placement | Other | PRF Group |
| xenogenic graft placementfilling the buccal gap with xenogenic graft after immediate dental implant placement | Other | Graft Group |
| no extra materialfilling the buccal gap with no material after immediate dental implant placement | Other | Control Group |
| tooth extractionextraction of tooth which is unrestorable | Procedure or surgery | Control Group, Graft Group, PRF Group |
| immediate implant placementputting dental implant into a socket which has been prepared with compatible drills | Procedure or surgery | Control Group, Graft Group, PRF Group |
| collagen membran placementplacing collagen membran on extraction socket after dental implant placement to cover all | Other | Control Group, Graft Group, PRF Group |
| raising flapraising the buccal flap with two vertical incision to cover extraction socket for primary closure | Procedure or surgery | Control Group, Graft Group, PRF Group |
Primary outcome
Primer Stabilization-Resonance Frequency Analysis
Time frame: at 0 day
initial measurement after placement by Osstell device
2 secondary outcomes
Seconder Stabilization-Resonance Frequency Analysis
Time frame: 120th day
Mesial-Distal and Horizontal Bone Loss
Time frame: 9th month
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 5 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Dental Implant Failure Nos
Recruiting
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sinus Perforation, Dental Implant Failure Nos
Recruiting
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
Mechanical Failure of Dental Implant Nos
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.
Alparslan Esen study chair
Consultant
Gökhan Gürses study director
Care Provider
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 placement, xenogenic graft placement and no extra material in people with Dental Implant Failure Nos, run by Necmettin Erbakan University 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 4 inclusion and 6 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 5 Mar 2019. 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?
Primer Stabilization-Resonance Frequency Analysis (time frame: at 0 day). 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 5 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.