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Non-invasive Treatment of Root Caries in Older Adults

NCT02647203 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2024-01-02

Study results available
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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

Conditions

  • Root Caries

Interventions

DRUG

Self-administered fluoridated dentifrices

Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.

Sponsors & Collaborators

  • Federal University of Rio Grande do Sul

    collaborator OTHER

  • University of Talca

    lead OTHER

Principal Investigators

  • Rodrigo A Giacaman, DDS, PhD · University of Talca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-11-30
Completion
2018-12-21

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647203 on ClinicalTrials.gov