Non-invasive Treatment of Root Caries in Older Adults (MIT-RCTalca)

December 28, 2023 updated by: Rodrigo A. Giacaman, DDS, PhD, University of Talca

Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • No State
      • Talca, No State, Chile, 3460000
        • Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Fluoride Toothpaste
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Drug: Self-administered fluoridated dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
Other Names:
  • Toothbrushing with high and standard fluoride dentifrices
Active Comparator: Standard Fluoride Toothpaste
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)
Drug: Self-administered fluoridated dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
Other Names:
  • Toothbrushing with high and standard fluoride dentifrices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Caries Activity
Time Frame: After 2 years of follow up
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
After 2 years of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)
Time Frame: Data registered at 2 years of follow-up
The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.
Data registered at 2 years of follow-up
Salivary Flow
Time Frame: Baseline and 2-year follow up
Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.
Baseline and 2-year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Talca

Collaborators

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Rodrigo A Giacaman, DDS, PhD, University of Talca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimated)

January 6, 2016

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-RC PIEI-ES
  • 1140623 (Other Grant/Funding Number: Fondecyt - Conicyt Chile)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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