Clinical trial NCT02360124: Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults
Official title: Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Caries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 323
Sex: ALL
Minimum age (years): 56
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of New Tooth Root Caries Lesions
timeFrame: 30 months
Secondary outcomes:
measure: Proportion of Inactive Root Caries Lesions
timeFrame: 30 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Edward CM Lo, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.