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Non-invasive Treatment of Root Caries in Older Adults

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02647203
Acronym
MIT-RCTalca
Enrollment
345
Registered
2016-01-06
Start date
2014-07-31
Completion date
2018-12-21
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Caries

Keywords

Fluoride toothpaste, Root caries, Randomized clinical trial

Brief 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

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.

Interventions

DRUGSelf-administered fluoridated dentifrices

Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
University of Talca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Root Caries ActivityAfter 2 years of follow upUsing Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.

Secondary

MeasureTime frameDescription
Salivary FlowBaseline and 2-year follow upUnstimulated 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.
Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)Data registered at 2 years of follow-upThe 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.

Countries

Chile

Participant flow

Participants by arm

ArmCount
High Fluoride Toothpaste
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: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
173
Standard Fluoride Toothpaste
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: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
172
Total345

Baseline characteristics

CharacteristicHigh Fluoride ToothpasteStandard Fluoride ToothpasteTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
173 Participants172 Participants345 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Education
9 - 12 years
70 Participants57 Participants127 Participants
Education
Less or equal than 8 years
42 Participants51 Participants93 Participants
Education
More than 12 years
61 Participants64 Participants125 Participants
Sex: Female, Male
Female
131 Participants127 Participants258 Participants
Sex: Female, Male
Male
42 Participants45 Participants87 Participants
Socioeconomic status
Lower
109 Participants112 Participants221 Participants
Socioeconomic status
Upper
64 Participants60 Participants124 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1420 / 138
other
Total, other adverse events
0 / 1420 / 138
serious
Total, serious adverse events
0 / 1420 / 138

Outcome results

Primary

Root Caries Activity

Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.

Time frame: After 2 years of follow up

Population: Independently-living older adults

ArmMeasureValue (MEAN)Dispersion
High Fluoride ToothpasteRoot Caries Activity3.72 Percentage of active lesions (2-years)Standard Deviation 12.32
Standard Fluoride ToothpasteRoot Caries Activity40.52 Percentage of active lesions (2-years)Standard Deviation 23.3
Secondary

Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)

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.

Time frame: Data registered at 2 years of follow-up

Population: Independently-living older adults

ArmMeasureValue (MEAN)Dispersion
High Fluoride ToothpasteOral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)10.71 score on a scaleStandard Deviation 9.56
Standard Fluoride ToothpasteOral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)11.28 score on a scaleStandard Deviation 9.25
Secondary

Salivary Flow

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.

Time frame: Baseline and 2-year follow up

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026