Dental Caries
Conditions
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.
Interventions
topical application of the SDF solution onto tooth root surfaces
OTHERWater as placebo
topical application of water as a placebo in the control arm
OTHERsaturated potassium iodide solution
topical application of SDF solution followed by KI solution onto tooth root surfaces
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
56 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Tooth Root Caries Lesions | 30 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Inactive Root Caries Lesions | 30 months | 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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.
Water as placebo: topical application of water as a placebo in the control arm | 108 |
| 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.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces | 107 |
| 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.
silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces | 108 |
| Total | 323 |
Baseline characteristics
| Characteristic | Control | Silver Diammine Fluoride | Silver Diammine Fluoride and KI | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 85 Participants | 95 Participants | 99 Participants | 279 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 12 Participants | 9 Participants | 44 Participants |
| Age, Continuous | 71.1 years STANDARD_DEVIATION 6.7 | 72.4 years STANDARD_DEVIATION 6.2 | 72.7 years STANDARD_DEVIATION 5.8 | 72.1 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Chinese | 108 participants | 107 participants | 108 participants | 323 participants |
| Region of Enrollment China | 108 participants | 107 participants | 108 participants | 323 participants |
| Sex: Female, Male Female | 86 Participants | 83 Participants | 84 Participants | 253 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 24 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 107 | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 | 0 / 107 | 0 / 108 |
Outcome results
Primary
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
Time frame: 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of New Tooth Root Caries Lesions | 1.1 new carious root surfaces | Standard Error 0.16 |
| Silver Diammine Fluoride | Number of New Tooth Root Caries Lesions | 0.43 new carious root surfaces | Standard Error 0.09 |
| Silver Diammine Fluoride and KI | Number of New Tooth Root Caries Lesions | 0.56 new carious root surfaces | Standard Error 0.11 |
Secondary
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
Time frame: 30 months
Population: The participants were the active root caries lesions found at baseline in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Inactive Root Caries Lesions | 45.0 percentage of inactive root caries |
| Silver Diammine Fluoride | Proportion of Inactive Root Caries Lesions | 90.0 percentage of inactive root caries |
| Silver Diammine Fluoride and KI | Proportion of Inactive Root Caries Lesions | 92.5 percentage of inactive root caries |