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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742142
• Other study ID #: UW12-296
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 13, 2016
• Last updated: April 15, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• water as placebo
topical application of water as a placebo in the control arm

Drug:
• silver diammine fluoride
topical application of the SDF solution onto tooth root surfaces

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong
China	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No