A Phase 1/2 interventional study of Self-administered fluoridated dentifrices in Root Caries, sponsored by University of Talca. Completed at 1 site in Chile. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by University of Talca · Phase 1/2, Interventional, and Treatment
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:
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 345 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →University of Talca is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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.
Also known as: Toothbrushing with high and standard fluoride dentifrices
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
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
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
| Milestone | High Fluoride Toothpaste | Standard Fluoride Toothpaste |
|---|---|---|
| Started | 173 | 172 |
| Completed | 148 | 149 |
| Not completed | 25 | 23 |
| Milestone | High Fluoride Toothpaste | Standard Fluoride Toothpaste |
|---|---|---|
| Started | 148 | 149 |
| Completed | 142 | 138 |
| Not completed | 6 | 11 |
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
| Percentage of active lesions (2-years) | High Fluoride Toothpaste | Standard Fluoride Toothpaste |
|---|---|---|
| Root Caries Activity | 3.72 ± 12.32 | 40.52 ± 23.30 |
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.
| score on a scale | High Fluoride Toothpaste | Standard Fluoride Toothpaste |
|---|---|---|
| Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) | 10.71 ± 9.56 | 11.28 ± 9.25 |
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.
Results for this outcome have not been posted.
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Fluoride Toothpaste | 0/142 (0%) | 0/142 (0%) | 0/142 (0%) |
| Standard Fluoride Toothpaste | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
| Age, Categorical(Participants) | High Fluoride Toothpaste | Standard Fluoride Toothpaste | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 173 | 172 | 345 |
| Sex: Female, Male(Participants) | High Fluoride Toothpaste | Standard Fluoride Toothpaste | Total |
|---|---|---|---|
| Female | 131 | 127 | 258 |
| Male | 42 | 45 | 87 |
| Socioeconomic status(Participants) | High Fluoride Toothpaste | Standard Fluoride Toothpaste | Total |
|---|---|---|---|
| Upper | 64 | 60 | 124 |
| Lower | 109 | 112 | 221 |
| Education(Participants) | High Fluoride Toothpaste | Standard Fluoride Toothpaste | Total |
|---|---|---|---|
| Less or equal than 8 years | 42 | 51 | 93 |
| 9 - 12 years | 70 | 57 | 127 |
| More than 12 years | 61 | 64 | 125 |
Plan to share: No
Ran from Jul 2014 to primary completion in Nov 2016, 28 months.
Results were first posted in Jan 2021, 4 years 2 months after primary completion.
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