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Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth

NCT04804423 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-06

No results posted yet for this study

Summary

This observational cohort study aims to evaluate the short-term (3 months) efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth (fluoride varnish application), and further compare it to a different fluoride therapy utilizing a silver-containing fluoride agent combined with potassium iodide solution.

Conditions

  • Dentin Hypersensitivity
  • Active Dental Caries

Interventions

DRUG

38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)

38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.

DRUG

Sodium fluoride varnish (generic name; Duraphat®)

22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.

Sponsors & Collaborators

  • SDI Limited

    collaborator UNKNOWN

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Mohamed H Abudrya, BDS, MSc. · The Department of Preventive and Pediatric Dentistry, University of Greifswald

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2021-03-31
Completion
2021-04-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804423 on ClinicalTrials.gov