Clinical trial NCT05765058: The Efficacy of Tooth Mouse, SFD and NaF in Caries Activity in Root Caries. A Randomized Clinical Trial
Official title: Randomized Clinical Trial on the Efficacy of Professionally and Self-applied Fluoride Varnishes, Solutions and Mousse on Arresting Root Caries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Root Caries
NaF
SDF
Tooth Mousse
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 136
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT (Randomized Clinical Study)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Significant inactivation of root caries lesion measured by visual tactile method
timeFrame: 18 months
measure: Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use measured by visual tactile method
timeFrame: 6 month to 1 year
measure: Inactivation of root caries due to regular use of fluoridated toothpaste and 6-monthly use of the fluoride varnish measured by visual tactile method
timeFrame: 6 months to one year
Secondary outcomes:
measure: Data collection of root caries prevalence (number of lesion and activity status)
timeFrame: 18 months
measure: Long-term clinical, radiographical and oral health related outcomes (Number of teeth present in the oral cavity) for senior population suffering from root caries
timeFrame: 18 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Zahnmedizinklinik University of Bern, Department of Restorative, Preventive and Paediatric Dentistry
Study officials:
affiliation: University of Bern
name: Anastasia Maklennan
role: PRINCIPAL_INVESTIGATOR
References: