Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas

NCT02742142 | Completed Phase 2

• 1 other identifier: UW12-296
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 2

Brief Summary

This study was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Baseline clinical examination was conducted by a single calibrated examiner in the social centers using an intra-oral LED light, mouth mirrors and probes. Subjects were randomly allocated into two study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes, i.e. whether new root caries developed and whether the active root caries found at baseline become arrested. Results of this study could provide the much needed evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most appropriate intervention for the prevention and management of this common dental disease of the older adults.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Tooth Root Caries Lesions

  Tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination

  24 months

Secondary Outcomes (1)

• Arrested root caries lesions

  24 months

Study Arms (2)

control

PLACEBO COMPARATOR

Distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) was painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.In addition, instructions on oral hygiene (OHI) tailored to the individual's condition was given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) was provided. The OHI and provision of toothpaste will be repeated at 6-month intervals.

Other: water as placebo

silver diammine fluoride

EXPERIMENTAL

the subjects received the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution was painted onto the exposed tooth root surfaces. This treatment was repeated after 12 and 24 months.

Drug: silver diammine fluoride

Interventions

water as placebo OTHER

topical application of water as a placebo in the control arm

Also known as: water

control

silver diammine fluoride DRUG

topical application of the SDF solution onto tooth root surfaces

Also known as: SDF

silver diammine fluoride

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have at least 5 teeth with exposed root surfaces and not indicated for extraction, and
• living in the community and have self-care ability for normal daily activities.

You may not qualify if:

• have life-threatening or serious health problems,
• have cognitive problems in communication or in receiving oral hygiene instructions
• have salivary gland diseases or received radiotherapy in the head and neck region.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Sun Yat-sen University: collaborator

Study Sites (2)

Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Water; silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Edward CM Lo, BDS, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 13, 2016
• First Posted: April 18, 2016
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)