Tooth MobilityNCT07188168
Assessment of Tooth Mobility Using the Osstell Device
A study testing Miller mobility measurement in people with Tooth Mobility, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
In this trial, it is hypothesized that mobility values obtained from natural teeth using the Osstell device-adapted with a specifically designed attachment-will demonstrate a statistically significant correlation with those obtained through established methods such as the Periotest and the Miller index. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tooth Mobility
- What is being tested?
- Miller mobility measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 Dec 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 18 and 45 years.
- Systemically healthy individuals
- Teeth which they have intact periodontium or treated because of periodontal disease.
Who cannot join
- History of psychiatric or neurological disorders.
- Impaired muscle coordination or neuromuscular dysfunction.
- Patients undergoing orthodontic treatment or with recent dental trauma affecting tooth stability.
- Presence of parafunctional habits such as bruxism (teeth grinding) or clenching.
- Presence of tooth pathologies such as endodontic or root resorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University
Antakya, Hatay, 31060
About this study
Official title: Objective Assessment of Tooth Mobility Using the Osstell Device: A Custom-Bonded Apparatus Trial
In this trial, it is hypothesized that mobility values obtained from natural teeth using the Osstell device-adapted with a specifically designed attachment-will demonstrate a statistically significant correlation with those obtained through established methods such as the Periotest and the Miller index. Accordingly, the aim of this study is to investigate the applicability of the Osstell device for assessing the mobility of natural teeth having different mobility grades and to evaluate the correlation between its measurements and those derived from conventional clinical mobility assessment methods.
Read the detailed description
A total of 16 patients, including 10 males and 6 females, were selected for the study, and mobility measurements were performed on 94 permanent teeth. All measurements were performed twice on each tooth by the same calibrated investigator to ensure consistency and eliminate inter-examiner variability. The repeated measurements were carried out under identical conditions for each assessment method (Miller mobility grading, Periotest M, and Osstell Beacon). To evaluate the intra-examiner reliability, the agreement of the two consecutive measurements was assessed using appropriate statistical methods. High intra-examiner agreement was considered indicative of the measurement reliability and reproducibility within the study. To assess tooth stability, resonance frequency analysis was performed using the Osstell Beacon device (Osstell, AB, Gothenburg, Sweden).
A custom-fabricated titanium bracket was used to accommodate the smartPeg and ensure standardized placement on each tooth. The bracket-like apparatus was carefully aligned with the long axis of the tooth and positioned apically.
Bracket specifications
- Raw material: Medical-grade titanium, precision-machined using Computer Numerical Control technology.
- Design: Cylindrical base with a centrally located, threaded slot for smartPeg insertion SmartPeg thread slot
- Internally threaded to enable clockwise insertion of the smartPeg (Figures 3b and 3c)
- Thread type: micro-thread,
- Tapered, centred aperture
- Diameter: approximately 1.2-1.5 mm Tooth contact surface
- Flat base designed to conform to the buccal surface of the tooth
- Smooth texture with micro-mechanical retention properties
- Suitable for adhesive fixation or direct contact application The apparatus was placed on the buccal surface of the respective tooth using flowable composite. Care was taken to ensure that the slot of the bracket designated for a smartPeg placement was oriented toward the root. Subsequently, the smartPeg was positioned in alignment with the root and torqued into place. After the smartPeg installation, two measurements were taken from different directions. The mean of the two readings was recorded as the final RFA value for each tooth. The Osstell Beacon was operated at a 2-5 mm distance, held perpendicular (90°) to the smartPeg without making contact. In this approach, the unit of measurement is the Implant Stability Quotient (ISQ), which is derived from resonance frequency analysis and ranges from 0 to 100, with higher values indicating greater stiffness at the implant-bone interface.The normality of the data distribution was tested using the Shapiro-Wilk test. The relationships between numerical variables were evaluated using Spearman's correlation coefficient. To assess the agreement between mobility classes and the Periotest and Osstell groups, Cohen's Kappa statistic was employed. The Kappa coefficient was interpreted as follows: values <0.00 indicated "poor agreement," 0.00-0.20 "slight agreement," 0.21-0.40 "fair agreement," 0.41-0.60 "moderate agreement," 0.61-0.80 "substantial agreement," and 0.81-1.00 "almost perfect agreement." The reliability of stability scores obtained from the Periotest and Osstell devices was evaluated using the Intraclass Correlation Coefficient (ICC). To determine inter-device agreement, ICC values were calculated based on a two-way mixed-effects model using the single measurement (average measure) approach. ICC values ≥0.75 were considered to indicate satisfactory reliability. All statistical analyses were performed using SPSS (Statistical Package for the Social Sciences), with a significance level set at 5% (p<0.05)
- Conditions
- Tooth Mobility
- Being tested
- Miller mobility measurement
- Keywords
- resonance frequency analysis, periotest, Miller mobility index
- Medical subject headings
- Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller mobility measurementDevice
Also called Periotest, Osstell Beacon
Tooth mobility at different levels of mobility was assessed using Miller, Periotest and Osstell, and was evaluated both subjectively and objectively.
| Study group | Role | What they receive |
|---|---|---|
| Mobility group | Other | The participants' mobile teeth were assessed using three different tooth mobility measurement methods, and the agreement among these measurements was evaluated. Receives: Device: Miller mobility measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miller measurement
Tooth mobility was classified from 0 to 3 according to the Miller index.
Measured: Baseline (first day)
Periotest measurements
Tooth mobility was measured using the Periotest device, with values ranging from -8 to +50.
Measured: Baseline (first day)
Osstell Measuements
Tooth resonance frequency was assessed using the Osstell device, and the values were classified as less than 60, between 60 and 69, and greater than 69.
Measured: Baseline (first day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth MobilityStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Fatih Arpag, Mustafa Kemal University
- Investigators
- Fariz Selimli, Assoc Prof, Study director, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188168
- Sponsor's protocol ID
- 2022/35 (Ethical number)
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdogan Eryildiz K, Selimli F, Haskan AC, Arpag OF. Objective Assessment of Tooth Mobility Using the Osstell Device: A Pilot Study. Diagnostics (Basel). 2026 Apr 9;16(8):1126. doi: 10.3390/diagnostics16081126.
PubMed 42072752
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Tooth Mobility Using the Osstell Device: A Custom-Bonded Apparatus Trial
- ClinicalTrials.gov ID
- NCT07188168
- Acronym / sponsor ID
- 2022/35 (Ethical number)
- Conditions
- Tooth Mobility
- Keywords
- resonance frequency analysis, periotest, Miller mobility index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2025 (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.
In this trial, it is hypothesized that mobility values obtained from natural teeth using the Osstell device-adapted with a specifically designed attachment-will demonstrate a statistically significant correlation with those obtained through established methods such as the Periotest and the Miller index. Accordingly, the aim of this study is to investigate the applicability of the Osstell device for assessing the mobility of natural teeth having different mobility grades and to evaluate the correlation between its measurements and those derived from conventional clinical mobility assessment methods.
Detailed description
A total of 16 patients, including 10 males and 6 females, were selected for the study, and mobility measurements were performed on 94 permanent teeth. All measurements were performed twice on each tooth by the same calibrated investigator to ensure consistency and eliminate inter-examiner variability. The repeated measurements were carried out under identical conditions for each assessment method (Miller mobility grading, Periotest M, and Osstell Beacon). To evaluate the intra-examiner reliability, the agreement of the two consecutive measurements was assessed using appropriate statistical methods. High intra-examiner agreement was considered indicative of the measurement reliability and reproducibility within the study. To assess tooth stability, resonance frequency analysis was performed using the Osstell Beacon device (Osstell, AB, Gothenburg, Sweden).
A custom-fabricated titanium bracket was used to accommodate the smartPeg and ensure standardized placement on each tooth. The bracket-like apparatus was carefully aligned with the long axis of the tooth and positioned apically.
Bracket specifications
- Raw material: Medical-grade titanium, precision-machined using Computer Numerical Control technology.
- Design: Cylindrical base with a centrally located, threaded slot for smartPeg insertion SmartPeg thread slot
- Internally threaded to enable clockwise insertion of the smartPeg (Figures 3b and 3c)
- Thread type: micro-thread,
- Tapered, centred aperture
- Diameter: approximately 1.2-1.5 mm Tooth contact surface
- Flat base designed to conform to the buccal surface of the tooth
- Smooth texture with micro-mechanical retention properties
- Suitable for adhesive fixation or direct contact application The apparatus was placed on the buccal surface of the respective tooth using flowable composite. Care was taken to ensure that the slot of the bracket designated for a smartPeg placement was oriented toward the root. Subsequently, the smartPeg was positioned in alignment with the root and torqued into place. After the smartPeg installation, two measurements were taken from different directions. The mean of the two readings was recorded as the final RFA value for each tooth. The Osstell Beacon was operated at a 2-5 mm distance, held perpendicular (90°) to the smartPeg without making contact. In this approach, the unit of measurement is the Implant Stability Quotient (ISQ), which is derived from resonance frequency analysis and ranges from 0 to 100, with higher values indicating greater stiffness at the implant-bone interface.The normality of the data distribution was tested using the Shapiro-Wilk test. The relationships between numerical variables were evaluated using Spearman's correlation coefficient. To assess the agreement between mobility classes and the Periotest and Osstell groups, Cohen's Kappa statistic was employed. The Kappa coefficient was interpreted as follows: values <0.00 indicated "poor agreement," 0.00-0.20 "slight agreement," 0.21-0.40 "fair agreement," 0.41-0.60 "moderate agreement," 0.61-0.80 "substantial agreement," and 0.81-1.00 "almost perfect agreement." The reliability of stability scores obtained from the Periotest and Osstell devices was evaluated using the Intraclass Correlation Coefficient (ICC). To determine inter-device agreement, ICC values were calculated based on a two-way mixed-effects model using the single measurement (average measure) approach. ICC values ≥0.75 were considered to indicate satisfactory reliability. All statistical analyses were performed using SPSS (Statistical Package for the Social Sciences), with a significance level set at 5% (p<0.05)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobility group | Other | Device: Miller mobility measurementThe participants' mobile teeth were assessed using three different tooth mobility measurement methods, and the agreement among these measurements was evaluated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals aged between 18 and 45 years.
- Systemically healthy individuals
- Teeth which they have intact periodontium or treated because of periodontal disease.
Key exclusion criteria (5 listed)
- History of psychiatric or neurological disorders.
- Impaired muscle coordination or neuromuscular dysfunction.
- Patients undergoing orthodontic treatment or with recent dental trauma affecting tooth stability.
- Presence of parafunctional habits such as bruxism (teeth grinding) or clenching.
- Presence of tooth pathologies such as endodontic or root resorption.
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 |
|---|---|---|
| Miller mobility measurementAlso: Periotest, Osstell BeaconTooth mobility at different levels of mobility was assessed using Miller, Periotest and Osstell, and was evaluated both subjectively and objectively. | Device | Mobility group |
Primary outcome
Miller measurement
Time frame: Baseline (first day)
Tooth mobility was classified from 0 to 3 according to the Miller index.
Periotest measurements
Time frame: Baseline (first day)
Tooth mobility was measured using the Periotest device, with values ranging from -8 to +50.
Osstell Measuements
Time frame: Baseline (first day)
Tooth resonance frequency was assessed using the Osstell device, and the values were classified as less than 60, between 60 and 69, and greater than 69.
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 23 Sep 2025.
- Derived from this study: PubMed 42072752Erdogan Eryildiz K, Selimli F, Haskan AC, Arpag OF. Objective Assessment of Tooth Mobility Using the Osstell Device: A Pilot Study. Diagnostics (Basel). 2026 Apr 9;16(8):1126. doi: 10.3390/diagnostics16081126.
- Individual participant dataSharing planned: No
Related trials for Tooth Mobility
Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Recruiting
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Tooth Mobility, Injectable Platelet-rich Fibrin
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Active, not recruitingObservational study
Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
Periodontitis, Tooth Mobility
Not yet recruitingObservational study
Physical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment
Charcot-Marie-Tooth Disease, Type IA, Peripheral Neuropathy Hereditary
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.
Fariz Selimli, Assoc Prof study director
Mustafa Kemal 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 Miller mobility measurement in people with Tooth Mobility, run by Mustafa Kemal 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 3 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: finished, as of the sponsor's last update on 23 Sep 2025. 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?
Miller measurement (time frame: Baseline (first day)). 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?
On the ClinicalTrials.gov record for NCT07188168, which also lists 1 linked publication.
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 23 Sep 2025.