Clinical Trials Directory

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

TypeNameDescription
DIAGNOSTIC_TESTResonance 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_TESTBite Force SensorAssessment 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.