High Fluoride and Root Caries in Older Adults (NIT-RCL-UTALCA)

NCT06749275 | Completed DMC

• 1 other identifier: SDF-RCL-SLeón
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to provide an effective solution for root caries lesions (RCLs), specifically in older persons with cognitive impairment through a non-invasive therapy with Silver Diamine Fluoride (SDF). We hypothesize that, due to its remineralizing potential and the cariostatic effect conferred by silver, 38% SDF (biannually applied) will be more effective than 5,000 ppm fluoride toothpastes or 22,600 ppm fluoride varnish in preventing and arresting RCLs in older adults with cognitive impairment. The aim of this project, therefore, is to compare the effectiveness of 38% SDF with high-fluoride toothpaste of 5,000 ppm and 5% fluoride varnish of 22,600 ppm, on the incidence and inactivation of RCLs in older adults with mild cognitive impairment. A double-blind randomized controlled clinical trial (RCT) will be conducted. One hundred thirty-two 65-year-old or older participants diagnosed as having mild cognitive impairment will be invited to participate. To be eligible, subjects must have at least 5 teeth and 1 active RCLs. Participating older adults with moderate or severe cognitive impairment, dementia, severe dependency, terminal illness, aggressive behavior and alcoholism, will be excluded from the study. Included subjects will be randomly assigned to one of the 3 following study arms (n=44 per group):

• Group 1 (Control): Toothbrushing twice per day with 5,000 ppm fluoride toothpaste
• Group 2: Applications of 5% fluoride varnish (22,600 ppm) every 3 months + toothbrushing twice per day with 1,450 ppm fluoride toothpaste.
• Group 3: Biannual applications of 38% SDF solution + toothbrushing twice per day with 1,450 ppm fluoride toothpaste. Incidence and lesion inactivation (arrest) using Nyvad's criteria for RCLs will be the primary outcomes to assess the effectiveness of the treatments. Clinical assessment every 6 months up to 2 years will be carried out. RCL incidence and Relative Risk (RR) will be obtained and compared among the treatment groups. This project will contribute novel scientific evidence on the effectiveness of SDF as a non-invasive therapy for RCLs with special focus on the increasing elderly population with cognitive impairment. The results of this project can be readily translated into dental practice to provide an effective and low-cost non-invasive tool to treat RCLs in cognitive impaired population, with potential implications in public health.

Conditions

Root Caries; Cognitive Impairment; Fluor

Outcome Measures

Primary Outcomes (1)

• Root caries

  Activity status of root caries lesions will be clinically assessed

  at 6, 12, 18 and 24 months

Study Arms (3)

5,000 ppm fluoride toothpaste

ACTIVE COMPARATOR

Toothbrushing twice per day with 5,000 ppm fluoride toothpaste + individualized Oral Hygiene Instruction (OHI). Toothpaste of 5,000 ppm of fluoride are considered as the control, since according to international clinical guidelines (Slayton et al. 2018) it would be the treatment of choice to treat RCLs.

Device: 5,000 ppm fluoride toothpaste

22,600 ppm fluoride varnish

EXPERIMENTAL

Applications of 5% fluoride varnish (22,600 ppm) every 3 months + toothbrushing twice per day with 1,450 ppm fluoride toothpaste + individualized OHI.

Device: 22,600 ppm fluoride varnish

38% SDF

EXPERIMENTAL

Biannual applications of 38% SDF solution + toothbrushing twice per day with 1,450 ppm fluoride toothpaste + individualized OHI.

Device: 38% SDF

Interventions

5,000 ppm fluoride toothpaste DEVICE

In group 1, toothbrushing with toothpaste of 5,000 ppm of fluoride twice per day for two minutes, after breakfast and before bedtime. Participants will be also instructed not to rinse with water after brushing and to only eliminate the excess of the dentifrice by spitting out. The amount of toothpaste to be used had to be about the size of a pea.

Also known as: Caristop 5,000 ppm

5,000 ppm fluoride toothpaste

22,600 ppm fluoride varnish DEVICE

The application protocol of 5% fluoride varnish will be used together with the 1,450 ppm paste with the same protocol of the group 1: toothbrushing with toothpaste of 1.450 ppm of fluoride twice per day for two minutes, after breakfast and before bedtime. Participants will be also instructed not to rinse with water after brushing and to only eliminate the excess of the dentifrice by spitting out. The amount of toothpaste to be used had to be about the size of a pea.

Also known as: Duraphat 22.600 ppm

22,600 ppm fluoride varnish

38% SDF DEVICE

The application protocol of 38% SDF annually will be used together with the 1,450 ppm paste with the same protocol of the group 2: toothbrushing with toothpaste of 1.450 ppm of fluoride twice per day for two minutes, after breakfast and before bedtime. Participants will be also instructed not to rinse with water after brushing and to only eliminate the excess of the dentifrice by spitting out. The amount of toothpaste to be used had to be about the size of a pea.

Also known as: Fagamin 44,800 ppm

38% SDF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People 65 years of age or older, with regular attendance at the Amancay day center at least once a week or belonging to the subsample with mild cognitive impairment of the MAUCO cohort.
• Medical diagnosis of mild cognitive impairment previously made by the psychiatrist of the Amancay team or by the MAUCO study and based on the diagnostic criteria of the International Association of Psychogeriatrics (Levy 1994).
• Have at least 5 teeth in the mouth and 1 active RCLs, according to the methodology of previous studies (León et al. 2019; Tan et al. 2010).
• To be able to do the toothbrushing yourself or, if you cannot do it, allow the person in charge to do it.

You may not qualify if:

• Severe dependent older adults and terminal patients (determined according to information from the Amancay team or by the MAUCO study).
• Aggressive older adults (who present aggressive or risky attitudes towards a member of the research team during visits).
• Alcoholic older adults (determined according to information from the Amancay team or by the MAUCO study).

Sponsors & Collaborators

• University of Talca: lead

Study Sites (1)

Faculty of Dentistry

Talca, Maule Region, 3460000, Chile

Location

MeSH Terms

Conditions

Root Caries; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Soraya León Araya, PhD

  University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fluoridated products and the different concentrations of toothpastes will be camouflaged and labeled by a member of the research team that does not participate in the clinical study who will keep them in separate boxes prior to delivery. The principal investigator and the outcomes assessor will not know the treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The total sample (132 individuals) will be divided randomly into 3 groups (44 per group) by means of a listing and using the online software http://www.random.org/ following a simple 1: 1: 1 assignment procedure in each group.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: April 12, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CL (1)