An interventional study of Group A and Group B in Root Caries, NaF and SDF, sponsored by University of Bern. Not yet recruiting at 1 site in Switzerland. Open to participants aged 45 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by University of Bern · Not applicable, Interventional, and Prevention
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.
The study aims to systematically screen the available literature in order to investigate the global root caries prevalence in particular focusing on its correlation with the published data from Switzerland. For this specific research, a comprehensive systematic review of the literature will be conducted. The aim is to summarize the level of evidence on the oral health status of the elderly, in order to gain insights in this relevant research field. By better understanding the actual situation, existing measures focusing on the situation in Switzerland will be identified by pointing of omissions/deficiencies in order to recommend new research directions for their use in future oral health outcomes research.
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
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 136 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Group A
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.
Other: Group B
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.
Other: Group C
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.
Other: Group D
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.
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.
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.
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.
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Feb 2027, 12 months later.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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