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

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ClinicalTrials.gov Identifier: NCT02360124
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : May 19, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Dental Caries
Interventions Drug: silver diammine fluoride
Other: Water as placebo
Other: saturated potassium iodide solution
Enrollment 323
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 108 107 108
Completed 80 95 82
Not Completed 28 12 26
Arm/Group Title Control Silver Diammine Fluoride Silver Diammine Fluoride and KI Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 108 107 108 323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 107 participants 108 participants 323 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  21.3%
12
  11.2%
9
   8.3%
44
  13.6%
>=65 years
85
  78.7%
95
  88.8%
99
  91.7%
279
  86.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 107 participants 108 participants 323 participants
71.1  (6.7) 72.4  (6.2) 72.7  (5.8) 72.1  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 107 participants 108 participants 323 participants
Female
86
  79.6%
83
  77.6%
84
  77.8%
253
  78.3%
Male
22
  20.4%
24
  22.4%
24
  22.2%
70
  21.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Chinese Number Analyzed 108 participants 107 participants 108 participants 323 participants
108 107 108 323
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 108 participants 107 participants 108 participants 323 participants
108 107 108 323
1.Primary Outcome
Title Number of New Tooth Root Caries Lesions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 80 95 82
Mean (Standard Error)
Unit of Measure: new carious root surfaces
1.1  (0.16) 0.43  (0.09) 0.56  (0.11)
2.Secondary Outcome
Title Proportion of Inactive Root Caries Lesions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The participants were the active root caries lesions found at baseline in each group.
Arm/Group Title Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Hide Arm/Group Description:

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.

Water as placebo: topical application of water as a placebo in the control arm

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

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

saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces

Overall Number of Participants Analyzed 20 40 40
Measure Type: Number
Unit of Measure: percentage of inactive root caries
45.0 90.0 92.5
Time Frame 30 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%)   0/108 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Silver Diammine Fluoride Silver Diammine Fluoride and KI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%)   0/108 (0.00%) 
It should be noted that the water in Hong Kong is fluoridated at an optimal concentration of 0.5 ppm, and whether SDF or SDF/KI is effective among elders living in non-fluoridated areas needs to be investigated in future clinical studies.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Prof. E.C.M. Lo
Organization: University of Hong Kong
Phone: 852-2859 0292
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02360124     History of Changes
Other Study ID Numbers: UW11-120
First Submitted: November 17, 2014
First Posted: February 10, 2015
Results First Submitted: April 13, 2016
Results First Posted: May 19, 2016
Last Update Posted: July 25, 2016