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

Randomized Clinical Trial on Preventing and Arresting Root Surface Caries Using Silver Diammine Fluoride Solution in Older Adults Living in Fluoridated and Non-fluoridated Areas

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: silver diammine fluoride; Other: water as placebo

Detailed Description

The primary and secondary outcome of this study was new root caries and arrested root caries. A root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. Arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. The status of each root surface was recorded using the codes recommended by the International Caries Detection and Assessment System (ICDAS Ⅱ) Coordinating Committee in 2009.

A mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in Hong Kong. Thus, in this study, a 24-month increment of 1.6 new decayed root surfaces and a standard deviation of 2 was anticipated. In order to show that a 50% difference in mean caries increment between the test and control groups was statistically significant using a 2-sample t-test at a 5% significance level and at an 80% power, a sample size of 100 subjects in each group was required. Allowing for a drop-out rate of 20% over 24 months, a total of 480 subjects (120 in each group each site) were needed.

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control; 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; topical application of water as a placebo in the control arm; Other Names: water
EXPERIMENTAL: silver diammine fluoride; 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; topical application of the SDF solution onto tooth root surfaces; Other Names: SDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrested root caries lesions	Active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination	24 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (ESTIMATE): April 18, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 18, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: UW12-296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will consider individual request case by case