Phase 2
N=345
Non-invasive Treatment of Root Caries in Older Adults
Root Caries
Bottom Line
View on ClinicalTrials.gov: NCT02647203 ↗Enrolled (actual)
345
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Root Caries Activity — 3.72; 40.52 Percentage of active lesions (2-years)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Self-administered fluoridated dentifrices (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Talca
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Root Caries Activity |
3.72; 40.52 | — |
| SECONDARY Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) |
10.71; 11.28 | — |
| SECONDARY Salivary Flow |
— | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02647203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.