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

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

Interventions

DEVICE

5,000 ppm fluoride toothpaste

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.

DEVICE

22,600 ppm fluoride varnish

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.

DEVICE

38% SDF

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.

Sponsors & Collaborators

• University of Talca

  lead OTHER

Principal Investigators

• Soraya León Araya, PhD · University of Talca

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-12

Primary Completion

2023-10-31

Completion

2023-10-31

Countries

• Chile

Study Locations