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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Root Caries; NaF; SDF; Tooth Mousse
• Intervention / Treatment: Other: Group A; Other: Group B; Other: Group C; Other: Group D

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 Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guglielmo Campus, Professor; Phone Number: +393473394544; Email: guglielmo.campus@unibe.ch
• Study Contact Backup: Name: Marcela Esteves-Oliveira, Professor; Phone Number: +41767248303; Email: marcella.esteves-oliveira@zmk.unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3007
    • Zahnmedizinklinik University of Bern, Department of Restorative, Preventive and Paediatric Dentistry
    • Contact: Anastasia Maklennan; Phone Number: +41767248303; Email: a.maclennan1@hotmail.com
    • Contact: Guglielmo Campus; Phone Number: +393473394544; Email: guglielmo.campus@unibe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: 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.
Placebo Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.
Sham Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	18 months

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Anastasia Maklennan, University of Bern

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 28, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries
• Other Study ID Numbers: Arresting root caries

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No