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

NCT ID: NCT02742142

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

water as placebo

Intervention Type: OTHER

topical application of water as a placebo in the control arm

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.

Group Type: EXPERIMENTAL

silver diammine fluoride

Intervention Type: DRUG

topical application of the SDF solution onto tooth root surfaces

Interventions

water as placebo

topical application of water as a placebo in the control arm

Intervention Type: OTHER

silver diammine fluoride

topical application of the SDF solution onto tooth root surfaces

Intervention Type: DRUG

Other Intervention Names

water; SDF

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward CM Lo, BDS, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Sun Yat-sen University

Guangzhou, Guangdong, China

The University of Hong Kong

Hong Kong, , China

Countries

China

Other Identifiers

UW12-296

Identifier Type: -

Identifier Source: org_study_id