Non-invasive Treatment for Root Caries Lesions in Older Adults with Cognitive Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 179
- Locations
- 2
- Primary Endpoint
- Root caries
Study Overview
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.
Detailed Description
This project aims to provide an effective solution for RCLs, specifically in older persons with cognitive impairment through a non-invasive therapy with SDF. SDF has a cariostatic effect - unlike any other fluoridated product -, does not require patient compliance, only needs one annual or biannual application, is easy to manipulate even at home care and is a low-cost product. Root caries is a highly prevalent oral health problem in the elderly population, and it is estimated to increase significantly over time, particularly in people with cognitive impairment. Therapies intended for RCLs have been mostly restorative and highly heterogeneous. Furthermore, clinical management of RCLs, especially in subjects with cognitive impairment, is challenging for the clinician. Limited evidence supports the non-invasive treatment of RCLs, some of them with SDF. In people with cognitive impairment, however, no evidence has been reported, but this approach could be the most advantageous for this complex population. Thus, SDF for RCLs management in this population appears as a novel and attractive solution to the problem. The present study corresponds to a blind randomized controlled clinical trial (RCT) according to the CONSORT (Consolidated Statement of Reporting Trials) statement (Moher et al. 2012), with 3 parallel groups. 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, prepared by a researcher without clinical participation in the RCT, in order to keep clinical researchers blind. This person will also be responsible for recruiting patients and assigning them to the appropriate group.
The participants of this study will belong to a day center located in Talca, Chile, focused in providing care to people over 65 years of age or older, with cognitive impairment.
Sample size: The sample size was determined for the ANOVA test of repeated measurements using G* Power. The a priori analysis considered an average effect size (ie, 0.3), a 5% error, a statistical power of 80% and a correlation between the initial and final measurements of 0.8, considering a 30% loss rate, according to a previous study (Tan et al. 2010). This calculation gives a total sample of 132 individuals, which would correspond to 44 participants per group.
Intervention and clinical examination: Participants will be randomly assigned to one of the three treatment groups:
• Group 1 or Control: Toothbrushing twice per day with 5,000 ppm fluoride toothpaste + individualized Oral Hygiene Instruction (OHI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Root caries
Time Frame: at 6, 12, 18 and 24 months
Activity status of root caries lesions will be clinically assessed
Secondary Outcomes
No secondary outcomes reported
Investigators
Soraya León Araya
Associate Professor
University of Talca