Missing TeethNCT06178796
Bone-Implant Contact Surface Influence on Dental Implant Stability
A study testing Dental implant in people with Missing Teeth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- 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
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Feb 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago,
- At least 18 years old,
- Maintaining good dental hygiene,
- Having a favorable occlusion,
- Having intact socket walls after extraction.
Who cannot join
- Any local or systemic disorders that had contraindications for dental implant insertion,
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: Bone-Implant Contact Surface Influence on Dental Implant Stability in Fresh Extraction and Healed Sites
This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites.
- Conditions
- Missing Teeth
- Being tested
- Dental implant
- Keywords
- Dental implant, primary stability, immediate placement
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
Dental implant placement
| Study group | Role | What they receive |
|---|---|---|
| With graft | Active comparator | Not described Receives: Device: Dental implant |
| Without graft | Active comparator | Not described Receives: Device: Dental implant |
| Delayed healing site | Active comparator | Not described Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Implant Stability Quotient (ISQ) values
Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows:
T0: baseline T1: follow-up of eight weeks T2: follow-up of twelve weeks
Measured: 12 weeks
Change in bone-implant contact surface
The tooth slated for extraction will be segmented from the preoperative CBCT data, followed by a virtual tooth extraction process. For each patient, intraoral surface scanning with the scanbodies in place will be conducted using an intraoral scanner. This datas will be overlaid onto the postoperative intraoral scan image. The area where the implant surface made contact with the extracted tooth surface will be identified as the surface without implant bone contact (BINC), while the remaining area will be designated the bone implant contact (BIC) surface. By subtracting the sum of the BINC and BIC from the entire implant surface, the implant surface facing the gap space (IGS) and its corresponding area on the BINC side will obtain. To isolate the BIC surface for measurement, the sum of the BINC and BIC from the sum of the BINC and IGS will subtracted. This result will then be added to the total implant surface measurement, divided by two, allowing for the measurement of the BIC surface.
Measured: 12 weeks
Primary insertion torque value
The torque value was recorded as insertion torque value of this case at the moment when the implant positioned at the 1mm under the socket wall edge and correct hex position. It gives numerical values from 0 to 100 (higher values mean higher stability).
Measured: 1 day At the implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Oct 2022
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178796
- Sponsor's protocol ID
- MUDHF_CER_01
- Status last verified
- Sep 2024
- First submitted
- 12 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone-Implant Contact Surface Influence on Dental Implant Stability in Fresh Extraction and Healed Sites
- ClinicalTrials.gov ID
- NCT06178796
- Acronym / sponsor ID
- MUDHF_CER_01
- Conditions
- Missing Teeth
- Keywords
- Dental implant, primary stability, immediate placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Dec 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.
This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| With graft | Active comparator | Device: Dental implant |
| Without graft | Active comparator | Device: Dental implant |
| Delayed healing site | Active comparator | Device: Dental implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago,
- At least 18 years old,
- Maintaining good dental hygiene,
- Having a favorable occlusion,
- Having intact socket walls after extraction.
Key exclusion criteria (2 listed)
- Any local or systemic disorders that had contraindications for dental implant insertion,
- Pregnant and lactating women.
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 implantDental implant placement | Device | Delayed healing site, With graft, Without graft |
Primary outcome
Change in Implant Stability Quotient (ISQ) values
Time frame: 12 weeks
Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: T0: baseline T1: follow-up of eight weeks T2: follow-up of twelve weeks
Change in bone-implant contact surface
Time frame: 12 weeks
The tooth slated for extraction will be segmented from the preoperative CBCT data, followed by a virtual tooth extraction process. For each patient, intraoral surface scanning with the scanbodies in place will be conducted using an intraoral scanner. This datas will be overlaid onto the postoperative intraoral scan image. The area where the implant surface made contact with the extracted tooth surface will be identified as the surface without implant bone contact (BINC), while the remaining area will be designated the bone implant contact (BIC) surface. By subtracting the sum of the BINC and BIC from the entire implant surface, the implant surface facing the gap space (IGS) and its corresponding area on the BINC side will obtain. To isolate the BIC surface for measurement, the sum of the BINC and BIC from the sum of the BINC and IGS will subtracted. This result will then be added to the total implant surface measurement, divided by two, allowing for the measurement of the BIC surface.
Primary insertion torque value
Time frame: 1 day At the implant placement
The torque value was recorded as insertion torque value of this case at the moment when the implant positioned at the 1mm under the socket wall edge and correct hex position. It gives numerical values from 0 to 100 (higher values mean higher stability).
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Missing Teeth, run by Marmara 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 5 inclusion and 2 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 19 Sep 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 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?
Change in Implant Stability Quotient (ISQ) values (time frame: 12 weeks). The study lists 3 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 Sep 2024.