NIPH Clinical Trials Search

Clinical Utility of Dental Coatings Containing Fluoride for Root Surface Caries Management

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Root surface exposure and early root surface caries
Date of first enrollment	28/08/2025
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	Application of fluoride dental coatings to root surfaces

Outcome(s)

Primary Outcome	Change from baseline in fluorescence reflectance readings using the Diagnodent pen
Secondary Outcome	(1) Depth of caries (2) Change from baseline in probing pocket depth (PPD) (3) Change from baseline in clinical attachment level (CAL)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 63age old
Gender	Both
Include criteria	(1) Patients who visited the Dental Treatment Department of Nagasaki University Hospital and had root surface exposure without parenchymal defect or early root surface caries with parenchymal defect of 0.5 mm or less on the buccal aspect (2) Age between 18 and 63 years at the time of consent (3) Able to perform self-care using a toothbrush (4) Patients who have been fully informed of the participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Exclude criteria	(1) Patients with a history of hypersensitivity such as rash or dermatitis to this clinical research device or methacrylic acid monomer (2) Patients with subjective symptoms such as pain during occlusion or hypersensitivity (3) Patients with a history of hypersensitivity treatment with photoinduced hypersensitivity suppressants based on medical records and interviews (4) Patients with a history of caries inhibitor (e.g., Saffolide) use based on medical records, interview, and visual examination of the subject teeth (5) Patients who are deemed inappropriate as research subjects by the principal investigator.