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

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ClinicalTrials.gov Identifier: NCT03654820
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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).


Condition or disease Intervention/treatment Phase
Root Caries Device: PVP-I solution combined with NaF varnish Device: SDF solution Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Using Silver Diammine Fluoride Solution and Combination of Povidone Iodine and Sodium Fluoride Varnish in Preventing Dental Root Caries in Elders: a Randomized, Double-blind, Non-inferiority Trial
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PVP-I solution combined with NaF varnish
4-monthly application of 10% povidone-iodine solution and 5% sodium fluoride varnish
Device: PVP-I solution combined with NaF varnish
4-monthly application of 10% povidone-iodine solution and 5% sodium fluoride varnish

Active Comparator: SDF treated
Annual application of 38% SDF solution
Device: SDF solution
Annual application of 38% SDF solution




Primary Outcome Measures :
  1. new root caries found in clinical examination [ Time Frame: 24 months ]
    development of new carious lesion on exposed tooth root as assessed in clinical examination where there is a soft decayed root surface on gentle probing with a blunt probe


Secondary Outcome Measures :
  1. arrested root caries found in clinical examination [ Time Frame: 24 months ]
    in the follow-up clinical examination, there is arrest of active caries lesions that were present at baseline and found to be a hard root surface upon gentle probing with a blunt probe



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have at least 6 teeth which are not indicated for extraction, and
  • have basic self-care ability.

Exclusion Criteria:

  • have serious debilitating health/medical conditions, and
  • have cognitive problems or major problems in communication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654820


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by The University of Hong Kong:
Study Protocol  [PDF] March 3, 2016


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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03654820     History of Changes
Other Study ID Numbers: UW 16-162
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Fluorides, Topical
Root Caries
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Povidone
Povidone-Iodine
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents