Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): silver diammine fluoride; Water as placebo; saturated potassium iodide solution
Intervention type(s): Drug; Other; Other
Intervention description(s): topical application of the SDF solution onto tooth root surfaces; topical application of water as a placebo in the control arm; topical application of SDF solution followed by KI solution onto tooth root surfaces
Other intervention name(s): SDF; Water; KI
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention