Health TrialsbyHealthPanel

The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial

ConditionsRoot CariesNaFSDFTooth Mousse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-95
SponsorUniversity of Bern

About this trial

The aim of this study is to summarize the current level of evidence on the prevalence of root caries in elderly population, evaluate the prevalence of root caries in elderly patients living in Canton Bern, Switzerland and to analyze the association between the data collected with demographic and relevant socioeconomic factors, provide relevant long-term clinical, radiographic and oral health related outcomes and to establish a pivotal reference in treatment of elderly patients by means of non-operative root caries treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being resident in the area of the canton Bern,

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,

Disqualifiers

Living in long-term care facilities, prisons, hospitals etc.,

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

136 Participants
are divided into 4 treatment groups
Group A: SDF solutionPlacebo comparator 1 intervention
Group B: NaF VarnishPlacebo comparator 1 intervention
Group C: Tooth mousseExperimental treatment 1 intervention
Group D: Placebo varnishSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Significant inactivation of root caries lesion measured by visual tactile method

Daily use of a regularly fluoridated toothpaste and daily use of a fluoridated tooth mouse inactivate significantly more root lesions than the daily use of a regularly fluoridated toothpaste and daily use of a placebo toothpaste

Time frame
18 months
2

Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use measured by visual tactile method

Daily use of a regularly fluoridated toothpaste and 6-monthly use of a fluoride solution inactivate significantly more root lesions than the daily use of a regularly fluoridated toothpaste and daily use of a placebo toothpaste

Time frame
6 month to 1 year
3

Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use of the fluoride varnish measured by visual tactile method

Daily use of a regularly fluoridated toothpaste and 6-monthly use of a fluoride varnish inactivate significantly more root lesions than the daily use of a regularly fluoridated toothpaste and daily use of a placebo toothpaste

Time frame
6 months to one year

Secondary outcomes

1

Data collection of root caries prevalence (number of lesion and activity status)

Summary of the world-wide current level of evidence on the prevalence of root caries in elderly population in Canton Bern, focusing on the published data from Switzerland.

Time frame
18 months
2

Long-term clinical, radiographical and oral health related outcomes (Number of teeth present in the oral cavity) for senior population suffering from root caries

Provision of relevant long-term clinical, radiographic and oral health related outcomes and to establish a pivotal reference in treatment of elderly patients by means of non-operative root caries treatment.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

Source ClinicalTrials.gov

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