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Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults

NCT02360124 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2016-07-25

Study results available
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Summary

This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects will be recruited from social centres for elders located in different districts in Hong Kong. Baseline clinical examination will be conducted by a single calibrated examiner in the social centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be randomly allocated into the three study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e. whether new root caries has developed and whether the active root caries found at baseline have become arrested (remineralized and hardened) or not. Photographs of the arrested lesions will be taken to assess their colour. Results of this study will provide the much needed evidence to guide the dental professionals in Hong Kong and worldwide in deciding on the most appropriate intervention for the prevention and treatment of this common dental disease of the older adults.

Conditions

  • Dental Caries

Interventions

DRUG

silver diammine fluoride

topical application of the SDF solution onto tooth root surfaces

OTHER

Water as placebo

topical application of water as a placebo in the control arm

OTHER

saturated potassium iodide solution

topical application of SDF solution followed by KI solution onto tooth root surfaces

Sponsors & Collaborators

  • 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
56 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • China

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 NCT02360124 on ClinicalTrials.gov