MedTrace Logo

Effectiveness on SDF Solution and PVP-I Combined NaF Varnish in Preventing Root Caries in Elders

NCT03654820 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2018-09-05

No results posted yet for this study

Summary

The main objective of this study is to compare the effectiveness and cost-effectiveness of 4-monthly application of 10% povidone iodine solution followed by 5% sodium fluoride varnish with those of annual application of 38% silver diammine fluoride solution on the prevention of new dental root caries in elders. A secondary objective is to compare the effectiveness of the two interventions mentioned above on arresting (halting the progression) active root surface caries in the elders, thus avoiding the need for placing dental restorations.

This proposed study is a randomized double-blind controlled clinical trial with 24-month follow-up. A total of 353 elders aged 60 years or above living in residential homes or attending long-term care facilities in different districts in Hong Kong were recruited. Baseline clinical examination will be conducted by two calibrated examiners in the homes using an intra-oral LED light, dental mirrors and probes. Subjects were randomly allocated to one of the two study groups:

1\) positive control - received annual application of 38% silver diammine fluoride solution; and 2) test - received application of 10% povidone iodine solution followed by application of 5% sodium fluoride varnish every 4 months. Follow-up examinations will be carried out after 12 and 24 months by the same blinded examiners to assess the clinical outcomes, i.e. whether new dental caries has developed and whether the active root surface caries lesions found at baseline have become arrested (hardened).

Conditions

  • Root Caries

Interventions

DEVICE

PVP-I solution combined with NaF varnish

4-monthly application of 10% povidone-iodine solution and 5% sodium fluoride varnish

DEVICE

SDF solution

Annual application of 38% SDF solution

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-03
Primary Completion
2020-01-15
Completion
2020-01-15

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 NCT03654820 on ClinicalTrials.gov