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

NCT05765058 | Not Yet Recruiting DMC

• 1 other identifier: Arresting root caries
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Root Caries; NaF; SDF; Tooth Mousse

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  6 months to one year

Secondary Outcomes (2)

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

  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

  18 months

Study Arms (4)

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.

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.

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.

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.

Other: Group D

Interventions

Group A OTHER

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.

SDF solution

Group B OTHER

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.

NaF Varnish

Group C OTHER

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.

Tooth mousse

Group D OTHER

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.

Placebo varnish

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Zahnmedizinklinik University of Bern, Department of Restorative, Preventive and Paediatric Dentistry

Bern, 3007, Switzerland

Location

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Anastasia Maklennan

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guglielmo Campus, Professor

CONTACT

+393473394544; guglielmocampus@gmail.com

Marcela Esteves-Oliveira, Professor

CONTACT

+41767248303; marcella.esteves-oliveira@zmk.unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and Assessor do not know to which group the testing product belongs
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT (Randomized Clinical Study)

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 13, 2023
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 28, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)