Tooth AnkylosisNCT07185711
RFA and Bite Force in COD Teeth
A study testing Resonance Frequency Analysis (RFA) and Bite Force Sensor in people with Tooth Ankylosis and Cemento-Osseous Dysplasia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the periodontal attachment and ankylosis status of teeth associated with cemento-osseous dysplasia (COD). Using resonance frequency analysis (RFA) and a bite force sensor, the stability of COD-associated teeth was measured and compared with contralateral healthy teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Ankylosis, Cemento-Osseous Dysplasia, Jaw Diseases / Diagnosis
- What is being tested?
- Resonance Frequency Analysis (RFA) and Bite Force Sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 15 Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cemento-osseous dysplasia (COD) based on panoramic radiographs
- Presence of at least one COD-associated tooth suitable for measurement
- Availability of a contralateral healthy tooth to serve as a control
- Teeth with healthy periodontal supporting tissues
- Patients aged ≥18 years
- Patients who have provided written informed consent
Who cannot join
- Presence of systemic diseases that could affect bone or periodontal structures (e.g., uncontrolled diabetes, osteoporosis, metabolic bone diseases)
- History of radiotherapy or chemotherapy in the head and neck region
- Teeth with extensive caries, mobility, or periodontal disease
- Patients with a history of orthodontic treatment or trauma in the relevant region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26480
About this study
Official title: Tooth Stability Assessment in Cemento-Osseous Dysplasia Using Resonance Frequency Analysis and Bite Force Sensor
This study aims to evaluate the periodontal attachment and ankylosis status of teeth associated with cemento-osseous dysplasia (COD). Using resonance frequency analysis (RFA) and a bite force sensor, the stability of COD-associated teeth was measured and compared with contralateral healthy teeth. These non-invasive and objective methods are expected to reveal the impact of COD lesions on the surrounding dentoalveolar structures.
Read the detailed description
Cemento-osseous dysplasias represent the most common group of benign fibro-osseous lesions, frequently detected in the mandible and often asymptomatic. Although they generally do not require treatment, the remodeling of bone and cementum-like tissues around the tooth roots has clinical significance in terms of periodontal attachment and ankylosis. The present study aims to investigate the ankylosis status of teeth associated with COD lesions at different stages by using objective measurement tools.
In each patient, COD-associated teeth and contralateral healthy teeth were evaluated. Measurements were performed using resonance frequency analysis (RFA) with the Osstell™ device and additionally by a bite force sensor to assess functional stability. For RFA, SmartPeg magnetic attachments were fixed to the occlusal surface with composite resin, and three measurements were obtained in both mesio-distal and bucco-lingual directions. Mean ISQ values were then recorded. After measurements, SmartPeg was carefully removed without leaving residues, and patient comfort was evaluated using a six-point numeric rating scale.
The obtained RFA and bite force values will be statistically analyzed to compare COD-associated teeth with healthy controls. Furthermore, the study seeks to determine differences in ankylosis tendency across various COD stages and their potential impact on periodontal ligament integrity. This approach may provide valuable insights for understanding the clinical course of COD and for planning surgical interventions in symptomatic cases
- Being tested
- Resonance Frequency Analysis (RFA), Bite Force Sensor
- Keywords
- pathology, Resonance Frequency Analysis, Bite Force
- Medical subject headings
- Tooth Ankylosis, Cementoma, Jaw Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance Frequency Analysis (RFA)Diagnostic test
Resonance frequency analysis performed with the Osstell™ device. SmartPeg was attached with composite resin to the occlusal surface of the tooth, and ISQ values were recorded in mesio-distal and bucco-lingual directions.
Bite Force SensorDiagnostic test
Assessment of maximum bite force using a bite force sensor. Measurements were performed on COD-associated teeth and contralateral healthy controls for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Teeth with Cemento-Osseous Dysplasia | Experimental | Teeth associated with cemento-osseous dysplasia were evaluated using Resonance Frequency Analysis (RFA) and a bite force sensor to assess ankylosis and stability. Receives: Diagnostic Test: Resonance Frequency Analysis (RFA); Diagnostic Test: Bite Force Sensor |
| Arm 2: Healthy Contralateral Teeth (Control Group) | Active comparator | Healthy contralateral teeth from the same patients, without cemento-osseous dysplasia, were evaluated using the same methods (RFA and bite force sensor) for comparison with COD-associated teeth. Receives: Diagnostic Test: Resonance Frequency Analysis (RFA); Diagnostic Test: Bite Force Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ) values by Resonance Frequency Analysis (RFA)
ISQ values obtained from COD-associated teeth and contralateral healthy teeth using the Osstell™ device. Measurements recorded in mesio-distal and bucco-lingual directions and averaged.
Measured: At baseline (single measurement per tooth)
Secondary outcomes (1)
Maximum Bite Force
Bite force recorded with a bite force sensor to compare functional stability of COD-associated teeth and contralateral healthy teeth.
Measured: At baseline (single measurement per tooth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start2 Jan 2025
- Primary completion5 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth AnkylosisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömür Dereci, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185711
- Sponsor's protocol ID
- EskisehirOU-Dereci-001
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olive J, Aparicio C. Periotest method as a measure of osseointegrated oral implant stability. Int J Oral Maxillofac Implants. 1990 Winter;5(4):390-400.
PubMed 2094658Barewal RM, Oates TW, Meredith N, Cochran DL. Resonance frequency measurement of implant stability in vivo on implants with a sandblasted and acid-etched surface. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):641-51.
PubMed 14579951
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Stability Assessment in Cemento-Osseous Dysplasia Using Resonance Frequency Analysis and Bite Force Sensor
- ClinicalTrials.gov ID
- NCT07185711
- Acronym / sponsor ID
- EskisehirOU-Dereci-001
- Keywords
- pathology, Resonance Frequency Analysis, Bite Force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 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.
This study aims to evaluate the periodontal attachment and ankylosis status of teeth associated with cemento-osseous dysplasia (COD). Using resonance frequency analysis (RFA) and a bite force sensor, the stability of COD-associated teeth was measured and compared with contralateral healthy teeth. These non-invasive and objective methods are expected to reveal the impact of COD lesions on the surrounding dentoalveolar structures.
Detailed description
Cemento-osseous dysplasias represent the most common group of benign fibro-osseous lesions, frequently detected in the mandible and often asymptomatic. Although they generally do not require treatment, the remodeling of bone and cementum-like tissues around the tooth roots has clinical significance in terms of periodontal attachment and ankylosis. The present study aims to investigate the ankylosis status of teeth associated with COD lesions at different stages by using objective measurement tools.
In each patient, COD-associated teeth and contralateral healthy teeth were evaluated. Measurements were performed using resonance frequency analysis (RFA) with the Osstell™ device and additionally by a bite force sensor to assess functional stability. For RFA, SmartPeg magnetic attachments were fixed to the occlusal surface with composite resin, and three measurements were obtained in both mesio-distal and bucco-lingual directions. Mean ISQ values were then recorded. After measurements, SmartPeg was carefully removed without leaving residues, and patient comfort was evaluated using a six-point numeric rating scale.
The obtained RFA and bite force values will be statistically analyzed to compare COD-associated teeth with healthy controls. Furthermore, the study seeks to determine differences in ankylosis tendency across various COD stages and their potential impact on periodontal ligament integrity. This approach may provide valuable insights for understanding the clinical course of COD and for planning surgical interventions in symptomatic cases
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Teeth with Cemento-Osseous Dysplasia | Experimental | Diagnostic Test: Resonance Frequency Analysis (RFA), Diagnostic Test: Bite Force SensorTeeth associated with cemento-osseous dysplasia were evaluated using Resonance Frequency Analysis (RFA) and a bite force sensor to assess ankylosis and stability. |
| Arm 2: Healthy Contralateral Teeth (Control Group) | Active comparator | Diagnostic Test: Resonance Frequency Analysis (RFA), Diagnostic Test: Bite Force SensorHealthy contralateral teeth from the same patients, without cemento-osseous dysplasia, were evaluated using the same methods (RFA and bite force sensor) for comparison with COD-associated teeth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with cemento-osseous dysplasia (COD) based on panoramic radiographs
- Presence of at least one COD-associated tooth suitable for measurement
- Availability of a contralateral healthy tooth to serve as a control
- Teeth with healthy periodontal supporting tissues
- Patients aged ≥18 years
Key exclusion criteria (4 listed)
- Presence of systemic diseases that could affect bone or periodontal structures (e.g., uncontrolled diabetes, osteoporosis, metabolic bone diseases)
- History of radiotherapy or chemotherapy in the head and neck region
- Teeth with extensive caries, mobility, or periodontal disease
- Patients with a history of orthodontic treatment or trauma in the relevant region
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 |
|---|---|---|
| Resonance Frequency Analysis (RFA)Resonance frequency analysis performed with the Osstell™ device. SmartPeg was attached with composite resin to the occlusal surface of the tooth, and ISQ values were recorded in mesio-distal and bucco-lingual directions. | Diagnostic test | Arm 1: Teeth with Cemento-Osseous Dysplasia, Arm 2: Healthy Contralateral Teeth (Control Group) |
| Bite Force SensorAssessment of maximum bite force using a bite force sensor. Measurements were performed on COD-associated teeth and contralateral healthy controls for comparison. | Diagnostic test | Arm 1: Teeth with Cemento-Osseous Dysplasia, Arm 2: Healthy Contralateral Teeth (Control Group) |
Primary outcome
Implant Stability Quotient (ISQ) values by Resonance Frequency Analysis (RFA)
Time frame: At baseline (single measurement per tooth)
ISQ values obtained from COD-associated teeth and contralateral healthy teeth using the Osstell™ device. Measurements recorded in mesio-distal and bucco-lingual directions and averaged.
1 secondary outcome
Maximum Bite Force
Time frame: At baseline (single measurement per tooth)
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 22 Sep 2025.
- Results publication: PubMed 2094658Olive J, Aparicio C. Periotest method as a measure of osseointegrated oral implant stability. Int J Oral Maxillofac Implants. 1990 Winter;5(4):390-400.
- Results publication: PubMed 14579951Barewal RM, Oates TW, Meredith N, Cochran DL. Resonance frequency measurement of implant stability in vivo on implants with a sandblasted and acid-etched surface. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):641-51.
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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 Resonance Frequency Analysis (RFA) and Bite Force Sensor in people with Tooth Ankylosis and Cemento-Osseous Dysplasia, run by Eskisehir Osmangazi 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 6 inclusion and 4 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 22 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?
Implant Stability Quotient (ISQ) values by Resonance Frequency Analysis (RFA) (time frame: At baseline (single measurement per tooth)). 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 NCT07185711, which also lists 2 linked publications.
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 22 Sep 2025.