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Investigation of early root caries diagnosis using optical hardness measurement

Exploratory study on early root caries diagnosis using an optical hardness tester

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062250104
Enrollment
20
Registered
2026-03-23
Start date
2026-03-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root surface caries

Interventions

For patients with at least one tooth with incipient root caries (ICDAS code I or higher), the hardness of the softened dentin surface of the tooth affected by root caries and the dentin surface of a s

Sponsors

Takashiba Shogo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients for participation in this study are those aged 65 or older who are able to provide written informed consent directly from themselves, who are currently non-smokers (past smoking history is not an issue), who are generally healthy or medically controlled (equivalent to ASA PS classification I or II), and who meet all of the following conditions: 1.Patients must be outpatients of the implementing institution. 2.Patients who undergo regular oral management. 3.Patients who have at least one tooth with early root surface caries (ICDAS: code I or higher).

Exclusion criteria

Exclusion criteria: The following patients or teeth are excluded from this study. 1.Patients diagnosed with Sjogren's syndrome 2.Patients with a history of head and neck cancer 3.Patients with significantly reduced saliva volume in the oral cavity whose masticatory stimulation saliva secretion test does not meet the normal value (saliva secretion volume: 10 mL/5 min) 4.Patients with nausea due to abnormal strangulation reflex, etc., which makes measurement using the optical hardness tester difficult. 5.Patients who are judged to have acid erosion by clinical research director or registered dentist. 6.other patients who are judged to be inappropriate to participate in the study by clinical research director or registered dentist.

Design outcomes

Primary

MeasureTime frame
Relationship Between Optical Hardness Measurements and Existing Clinical Criteria for Operative Intervention in Early Root Caries

Secondary

MeasureTime frame
1. Comparison of hardness measurements between sound dentin and carious regions affected by initial root caries 2. Success rate of measurements and frequency of errors or malfunctions during measurement - A measurement is defined as successful when no measurement errors occur. - A measurement is considered unsuccessful if no measurement value is obtained, if a clear error message is displayed, or if the measurer determines that the measurement is clearly abnormal or inappropriate. 3. Degree of oral dryness of the participants 4. Survey on user experience of the optical hardness tester BEL-CODE (questionnaire using a VAS scale)

Contacts

Public ContactKeisuke Okubo

Okayama University Hospital

okubok@okayama-u.ac.jp+81-86-235-6677

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026