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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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 groups in NCT07188168
Study groupRoleWhat they receive
Mobility groupOtherThe 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.

  1. Miller measurement

    Tooth mobility was classified from 0 to 3 according to the Miller index.

    Measured: Baseline (first day)

  2. Periotest measurements

    Tooth mobility was measured using the Periotest device, with values ranging from -8 to +50.

    Measured: Baseline (first day)

  3. 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.

  1. First posted23 Sep 2025
  2. Study start1 Jun 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2023

Resources

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)
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

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.

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