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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

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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: silver diammine fluoride Other: Water as placebo Other: saturated potassium iodide solution Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults
Study Start Date : January 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Other: Water as placebo
topical application of water as a placebo in the control arm
Other Name: Water

Experimental: 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.
Drug: silver diammine fluoride
topical application of the SDF solution onto tooth root surfaces
Other Name: SDF

Active Comparator: 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.
Drug: silver diammine fluoride
topical application of the SDF solution onto tooth root surfaces
Other Name: SDF

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




Primary Outcome Measures :
  1. Number of New Tooth Root Caries Lesions [ Time Frame: 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 Outcome Measures :
  1. Proportion of Inactive Root Caries Lesions [ Time Frame: 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



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Ages Eligible for Study:   56 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360124


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Edward CM Lo, BDS, PhD The University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02360124     History of Changes
Other Study ID Numbers: UW11-120
First Posted: February 10, 2015    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: July 25, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We consider individual request case by case

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs