CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 323 enrolled
Drug / intervention
silver diammine fluoride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02360124
NCT02360124Phase 3Completed

Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults

The University of Hong Kong·interventional·Posted Feb 10, 2015·Updated Jul 25, 2016

In Brief

A Phase 3 clinical trial evaluating silver diammine fluoride, Water as placebo, and 1 other intervention for Dental Caries. Completed, enrolled 323 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2015
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.4 years ago

Interventions

silver diammine fluoridedrug

topical application of the SDF solution onto tooth root surfaces

Water as placeboother

topical application of water as a placebo in the control arm

saturated potassium iodide solutionother

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