Non-invasive Treatment of Root Caries in Older Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT02647203
• Date of registration: 07/12/2015
• Prospective Registration: No
• Primary sponsor: University of Talca
• Public title: Non-invasive Treatment of Root Caries in Older Adults MIT-RCTalca
• Scientific title: Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults
• Date of first enrolment: July 2014
• Target sample size: 345
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02647203
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Chile

Contacts

• Name: Rodrigo A Giacaman, DDS, PhD
• Affiliation: University of Talca

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Root Caries

Intervention(s)

Drug: Self-administered fluoridated dentifrices

Primary Outcome(s)

Root Caries Activity [Time Frame: After 2 years of follow up]

Secondary Outcome(s)

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]

Salivary Flow [Time Frame: Baseline and 2-year follow up]

Secondary ID(s)

1140623

NI-RC PIEI-ES

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Federal University of Rio Grande do Sul

Results

• Results available: Yes
• Date Posted: 05/01/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02647203