Overview

This trial is active, not recruiting.

Condition root caries
Treatment self-administered fluoridated dentifrices
Phase phase 1
Sponsor University of Talca
Collaborator Federal University of Rio Grande do Sul
Start date July 2014
End date July 2017
Trial size 316 participants
Trial identifier NCT02647203, 1140623, NI-RC PIEI-ES

Summary

This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.

Follow-up will be carries out every 6 months for two years to assess:

- Root caries incidence.

- Lesion arresting

- Changes in salivary flow

- Microbiology pattern shift

- Variations in oral health- related quality of life by OHIP-14 Sp

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
self-administered fluoridated dentifrices Toothbrushing with high and standard fluoride dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
(Active Comparator)
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
self-administered fluoridated dentifrices Toothbrushing with high and standard fluoride dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.

Primary Outcomes

Measure
Root caries incidence by the Root Caries Index (RCI) expressed as percentage.
time frame: Up to 3 years

Secondary Outcomes

Measure
Oral Health related quality of life, measured by the Oral Health Impact Profile (OHIP-14 Sp)
time frame: Up to 3 years
Microbiology - recovered CFU/biofilm from the root surface biofilm.
time frame: Up to 1 year
Root caries inactivation - Percentage of lesions that changed from active to inactive (arrested)
time frame: Up to 4 years
Salivary flow - Unstimulated and Stimulated salivary flow in mL per min.
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - 60 + years old - community-dwelling - living in a community with fluoridated water - had five or more of their own teeth - with ≥ 1 root caries lesion Exclusion Criteria: - cognitive impairment - alcoholism

Additional Information

Official title Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults
Principal investigator Rodrigo A Giacaman, DDS, PhD
Description Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment. Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults. Methodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms; Group 1: toothpaste 1.450 ppm F- Group 2: toothpaste 5.000 ppm F- Dependent variables. Root caries incidence and activity, cariogenic bacteria and oral health-related quality of life will be assessed upon completion of the study and compared with baseline scores. Expected results. Based on some previous data available, it is expected that a non-invasive therapy for root caries based on low-fluoride concentration will be less effective than high fluoride therapies in inactivating root caries lesions. These results may be used in novel therapeutic programs at the community level, as well as in private practice. Furthermore, these studies will shed light on potential mechanisms associated with non-invasive treatment of root caries, from a microbiology stand point. Since a non-invasive approach decreases costs and increases coverage of dental care for older adults, these results may contribute to increase access to care for the usually vulnerable population of older adults.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Talca.