Root CariesNCT05765058
The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial
A study testing Group A, Group B and Group C in people with Root Caries and NaF, run by University of Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Caries, NaF, SDF
- What is being tested?
- Group A, Group B and Group C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2026to 28 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
- Written declaration of informed consent,
- Capacity to understand questionnaire items related to the compliance of the trial.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Zahnmedizinklinik University of Bern, Department of Restorative, Preventive and Paediatric Dentistry
Bern, 3007
Anastasia Maklennan, +41767248303, a.maclennan1@hotmail.com
Guglielmo Campus, +393473394544, guglielmocampus@gmail.com
About this study
Official title: Randomized Clinical Trial on the Efficacy of Professionally and Self-applied Fluoride Varnishes, Solutions and Mousse on Arresting Root Caries
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.
Read the detailed description
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
- 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
- Root Caries, NaF, SDF, Tooth Mousse
- Being tested
- Group A, Group B, Group C, Group D
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
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 BOther
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 COther
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 DOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SDF solution | Placebo comparator | 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. Receives: Other: Group A |
| NaF Varnish | Placebo comparator | 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. Receives: Other: Group B |
| Tooth mousse | Experimental | 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. Receives: Other: Group C |
| Placebo varnish | Sham comparator | 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. Receives: Other: Group D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months to one year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CariesStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT (Randomized Clinical Study)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasia Maklennan, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765058
- Sponsor's protocol ID
- Arresting root caries
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Efficacy of Professionally and Self-applied Fluoride Varnishes, Solutions and Mousse on Arresting Root Caries
- ClinicalTrials.gov ID
- NCT05765058
- Acronym / sponsor ID
- Arresting root caries
- Conditions
- Root Caries, NaF, SDF, Tooth Mousse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- RCT (Randomized Clinical Study)
| Arm | Type | Receives |
|---|---|---|
| SDF solution | Placebo comparator | Other: Group ASubjects 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. |
| NaF Varnish | Placebo comparator | Other: Group BSubjects 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. |
| Tooth mousse | Experimental | Other: Group CSubjects 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. |
| Placebo varnish | Sham comparator | Other: Group DSubjects 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. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
- Written declaration of informed consent,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AApplication 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. | Other | SDF solution |
| Group BApplication 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. | Other | NaF Varnish |
| Group CApplication 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. | Other | Tooth mousse |
| Group DApplication 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. | Other | Placebo varnish |
Primary outcome
Significant inactivation of root caries lesion measured by visual tactile method
Time frame: 18 months
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
Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use measured by visual tactile method
Time frame: 6 month to 1 year
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
Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use of the fluoride varnish measured by visual tactile method
Time frame: 6 months to one year
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
2 secondary outcomes
Data collection of root caries prevalence (number of lesion and activity status)
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
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anastasia Maklennan principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A, Group B and Group C in people with Root Caries and NaF, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guglielmo Campus, Professor (+393473394544, guglielmocampus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant inactivation of root caries lesion measured by visual tactile method (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.