Phase 2 Completed N=345 Randomized Quadruple-blind Treatment

Non-invasive Treatment of Root Caries in Older Adults

Root Caries

Source: ClinicalTrials.gov NCT02647203 ↗

Enrolled (actual)

345

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Root Caries Activity — 3.72; 40.52 Percentage of active lesions (2-years)

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

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.