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

NCT03654820 | Unknown DMC

• 1 other identifier: UW 16-162
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

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).

Conditions

Root Caries

Outcome Measures

Primary Outcomes (1)

• new root caries found in clinical examination

  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

  24 months

Secondary Outcomes (1)

• arrested root caries found in clinical examination

  24 months

Study Arms (2)

PVP-I solution combined with NaF varnish

EXPERIMENTAL

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

Device: PVP-I solution combined with NaF varnish

SDF treated

ACTIVE COMPARATOR

Annual application of 38% SDF solution

Device: SDF solution

Interventions

PVP-I solution combined with NaF varnish DEVICE

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

PVP-I solution combined with NaF varnish

SDF solution DEVICE

Annual application of 38% SDF solution

SDF treated

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: August 3, 2017
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)