MedTrace Logo

Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas

NCT02742142 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2016-04-18

No results posted yet for this study

Summary

This study was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Baseline clinical examination was conducted by a single calibrated examiner in the social centers using an intra-oral LED light, mouth mirrors and probes. Subjects were randomly allocated into two study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes, i.e. whether new root caries developed and whether the active root caries found at baseline become arrested. Results of this study could provide the much needed evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most appropriate intervention for the prevention and management of this common dental disease of the older adults.

Conditions

  • Dental Caries

Interventions

OTHER

water as placebo

topical application of water as a placebo in the control arm

DRUG

silver diammine fluoride

topical application of the SDF solution onto tooth root surfaces

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Edward CM Lo, BDS, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT02742142 on ClinicalTrials.gov