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Completed

NCT Number: NCT07185711

RFA and Bite Force in COD Teeth

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 Sensor

Diagnostic Test

Assessment of maximum bite force using a bite force sensor. Measurements were performed on COD-associated teeth and contralateral healthy controls for comparison.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Bite Force

    Time frame: At baseline (single measurement per tooth)

    Bite force recorded with a bite force sensor to compare functional stability of COD-associated teeth and contralateral healthy teeth.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Tooth Stability Assessment in Cemento-Osseous Dysplasia Using Resonance Frequency Analysis and Bite Force Sensor

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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