Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults

Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults

This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects will be recruited from social centres for elders located in different districts in Hong Kong. Baseline clinical examination will be conducted by a single calibrated examiner in the social centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be randomly allocated into the three study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e. whether new root caries has developed and whether the active root caries found at baseline have become arrested (remineralized and hardened) or not. Photographs of the arrested lesions will be taken to assess their colour. Results of this study will provide the much needed evidence to guide the dental professionals in Hong Kong and worldwide in deciding on the most appropriate intervention for the prevention and treatment of this common dental disease of the older adults.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Water as placebo; Drug: silver diammine fluoride; Other: saturated potassium iodide solution

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. Color of the arrested root caries lesion was classified into one of four types according to PANTONE® color plates placed next to the lesion (Fig 1), namely yellow (7401U), light brown (1245U), dark brown (4635U), and black (Black U).

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 30-month increment of 2 new decayed root surfaces was anticipated. The ratio of the mean to the standard deviation of the root caries increment was expected to be around 1:1.5. In order to show that a 50% difference in mean caries increment between the highest and the lowest values in the three groups was statistically significant at a 5% significance level and at an 80% power, 80 subjects in each group was required. Allowing for a drop-out rate of 25% over 30 months, a total of 300 subjects (100 in each group) were needed.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; instructions on oral hygiene (OHI) tailored to the individual's condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.	Other: Water as placebo; topical application of water as a placebo in the control arm; Other Names: Water
Experimental: silver diammine fluoride; the subjects will receive 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 will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.	Drug: silver diammine fluoride; topical application of the SDF solution onto tooth root surfaces; Other Names: SDF
Active Comparator: silver diammine fluoride and KI; the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.	Drug: silver diammine fluoride; topical application of the SDF solution onto tooth root surfaces; Other Names: SDF; Other: saturated potassium iodide solution; topical application of SDF solution followed by KI solution onto tooth root surfaces; Other Names: KI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of New Tooth Root Caries Lesions	the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Inactive Root Caries Lesions	the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline	30 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• Li R, Lo ECM, Liu BY, Wong MCM, Chu CH. Randomized Clinical Trial on Preventing Root Caries among Community-Dwelling Elders. JDR Clin Trans Res. 2017 Jan;2(1):66-72. doi: 10.1177/2380084416668491. Epub 2016 Sep 28.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 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: UW11-120

Plan for Individual participant data (IPD)

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