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CompletedNCT07185711Updated Sep 22, 2025

RFA and Bite Force in COD Teeth

An interventional study of Resonance Frequency Analysis (RFA) and Bite Force Sensor in Tooth Ankylosis, Cemento-Osseous Dysplasia and Jaw Diseases / Diagnosis, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2025, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Tooth Ankylosis
  • Cemento-Osseous Dysplasia
  • Jaw Diseases / Diagnosis

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Keywords

  • pathology
  • Resonance Frequency Analysis
  • Bite Force
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 17 is below the median of 80 across 732 interventional studies indexed under Disease.

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Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Arm 1: Teeth with Cemento-Osseous Dysplasia

    Teeth associated with cemento-osseous dysplasia were evaluated using Resonance Frequency Analysis (RFA) and a bite force sensor to assess ankylosis and stability.

    Diagnostic Test: Resonance Frequency Analysis (RFA) · Diagnostic Test: Bite Force Sensor

  • Active comparator
    Arm 2: Healthy Contralateral Teeth (Control Group)

    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.

    Diagnostic Test: Resonance Frequency Analysis (RFA) · Diagnostic Test: Bite Force Sensor

Interventions

  • 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 Sensor

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At baseline (single measurement per tooth)

07

Study locations

1 site
  • Eskişehir Osmangazi University
    Eskişehir, 26480, Turkey (Türkiye)
08

References and documents

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 2094658 ↗
  • Barewal 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07185711
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Ömür Dereci (Prof., Eskisehir Osmangazi University) — Principal investigator
First posted
Sep 22, 2025
Start date
Jan 2, 2025
Primary completion
Sep 5, 2025
Completion
Sep 15, 2025
Last update
Sep 22, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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