Clinical trial
Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults
Name
NI-RC PIEI-ES
Description
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
Trial arms
Trial start
2014-07-01
Estimated PCD
2016-11-01
Trial end
2018-12-21
Status
Completed
Phase
Early phase I
Treatment
Self-administered fluoridated dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
Arms:
High Fluoride Toothpaste, Standard Fluoride Toothpaste
Other names:
Toothbrushing with high and standard fluoride dentifrices
Size
345
Primary endpoint
Root Caries Activity
After 2 years of follow up
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 345, 'type': 'ACTUAL'}}
Updated at
2024-01-02
1 organization
1 product
1 indication
Organization
University of TalcaIndication
Root Caries