Trials / Completed
CompletedNCT07185711
RFA and Bite Force in COD Teeth
Tooth Stability Assessment in Cemento-Osseous Dysplasia Using Resonance Frequency Analysis and Bite Force Sensor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Eskisehir Osmangazi University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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 | Bite Force Sensor | Assessment of maximum bite force using a bite force sensor. Measurements were performed on COD-associated teeth and contralateral healthy controls for comparison. |
Timeline
- Start date
- 2025-01-02
- Primary completion
- 2025-09-05
- Completion
- 2025-09-15
- First posted
- 2025-09-22
- Last updated
- 2025-09-22
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07185711. Inclusion in this directory is not an endorsement.