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

NCT ID: NCT02360124

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

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.

Conditions

Dental Caries

Study Design

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

Study Groups

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.

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 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.

Group Type: EXPERIMENTAL

silver diammine fluoride

Intervention Type: DRUG

topical application of the SDF solution onto tooth root surfaces

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.

Group Type: ACTIVE_COMPARATOR

silver diammine fluoride

Intervention Type: DRUG

topical application of the SDF solution onto tooth root surfaces

saturated potassium iodide solution

Intervention Type: OTHER

topical application of SDF solution followed by KI solution onto tooth root surfaces

Interventions

silver diammine fluoride

topical application of the SDF solution onto tooth root surfaces

Intervention Type: DRUG

Water as placebo

topical application of water as a placebo in the control arm

Intervention Type: OTHER

saturated potassium iodide solution

topical application of SDF solution followed by KI solution onto tooth root surfaces

Intervention Type: OTHER

Other Intervention Names

SDF; Water; KI

Eligibility Criteria

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.

• Minimum Eligible Age: 56 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

The University of Hong Kong

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30938645 (View on PubMed)

Other Identifiers

UW11-120

Identifier Type: -

Identifier Source: org_study_id