The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial
NCT ID: NCT05765058
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
136 participants
INTERVENTIONAL
2026-02-01
2027-06-28
Brief Summary
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Detailed Description
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Thereafter, the study will evaluate the prevalence of root caries in the elderly population living in Canton Bern, Switzerland and analyze the association between the oral data collected with demographic, socioeconomic factors and compromising health conditions. Therefore, a randomized clinical trial with participants older than 45 years limited to Canton Bern will be conducted. To be representative of Canton Bern, a sample size calculation of a total of 136 subjects (sample size calculation n=107 + 25 per cent drop-out) will be applied.
Long-term non-operative treatment results as well as the oral-health status of elderly patients (\>45 years of age) having received one of the non-operative treatment methods for root caries treatment will be assessed. From the original pool of patients from Canton Bern all selected individuals will receive one of the non-operative treatment methods for root caries treatment. For the present study, only data collected from patients older than 45 years old at the time of the clinical examination will be used for analysis. The clinical appearance of each root caries lesion will be recorded longitudinally at intervals of up to 6 months and followed up to 18 months. At every single visit the lesions will be clinically and photographically characterized with respect to texture (light probing), color and surface structure (visual inspection and photographic recording) and presence or absence of plaque. If occurrence of presence of plaque and/or gingival trauma is detected, they will be accompanied by oral health instruction at every visit. All participants of the study will receive
* Regular therapy with fluoride toothpaste,
* Placebo or fluoride tooth mousse for at home-use and additionally,
* Twice-yearly professional placebo or fluoride varnish/solution application.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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SDF solution
Subjects will receive one of the available non-operative treatment methods for root caries, namely silver diamine fluoride solution (SDF \[38% F-, 38,000 ppm F\]) twice yearly applied professionally by a dentist, Placebo Tooth mousse twice daily applied at home by the subject and will perform tooth brushing with regular fluoridated toothpaste (NaF, \[0.32% F-, 1,450 ppm F\]) twice daily.
Group A
Application of SDF (silver diamine fluoride) solution on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
NaF Varnish
Subjects will receive one of the available non-operative treatment methods for root caries, namely sodium fluoride varnish (NaF, \[5% F-, 22,600 ppm F\]) twice yearly applied professionally by a dentist, Placebo Tooth mousse twice daily applied at home by the subject and will perform tooth brushing with regular fluoridated toothpaste (NaF, \[0.32% F-, 1,450 ppm F\]) toothpaste twice daily.
Group B
Application of Sodium Fluoride varnish on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Tooth mousse
Subjects will receive placebo varnish (water-based) twice yearly applied professionally by a dentist, Biosmalto Tooth mousse twice daily applied at home by the subject and will perform tooth brushing with regular fluoridated toothpaste (NaF, \[0.32% F-, 1,450 ppm F\]) toothpaste twice daily.
Group C
Application of Placebo varnish (water-based) solution on the root caries lesions twice yearly in a professional setting. Application of Biosmalto tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Placebo varnish
Subjects will receive placebo varnish (water-based) twice yearly applied professionally by a dentist, Placebo tooth mousse twice daily applied at home by the subject and will perform tooth brushing with regular fluoridated toothpaste (NaF, \[0.32% F-, 1,450 ppm F\]) toothpaste twice daily.
Group D
Application of Placebo varnish (water-based) solution on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Interventions
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Group A
Application of SDF (silver diamine fluoride) solution on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Group B
Application of Sodium Fluoride varnish on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Group C
Application of Placebo varnish (water-based) solution on the root caries lesions twice yearly in a professional setting. Application of Biosmalto tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Group D
Application of Placebo varnish (water-based) solution on the root caries lesions twice yearly in a professional setting. Application of Placebo tooth mousse by the subject twice daily. Regular tooth brushing with standardized fluoridated toothpaste.
Eligibility Criteria
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Inclusion Criteria
* Age \>44 years,
* Three or more root caries
* Lesions ICDAS (W1 or W2) on the first premolar, canines and front teeth of the upper and lower jaw,
* Written declaration of informed consent,
* Capacity to understand questionnaire items related to the compliance of the trial.
Exclusion Criteria
* Known allergic reaction to oral hygiene products and/or medication and/or dental material previously used in the mouth or pharynx,
* Inability to follow the procedures of filling out questionnaires or clinical examination, e.g. physical inability to fill in questionnaires
45 Years
95 Years
ALL
Yes
Sponsors
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University of Bern
OTHER
Responsible Party
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Principal Investigators
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Anastasia Maklennan
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
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Zahnmedizinklinik University of Bern, Department of Restorative, Preventive and Paediatric Dentistry
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Arresting root caries
Identifier Type: -
Identifier Source: org_study_id
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