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

NCT02360124 | Completed Phase 2 Results

• 1 other identifier: UW11-120
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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

  30 months

Secondary Outcomes (1)

• Proportion of Inactive Root Caries Lesions

  30 months

Study Arms (3)

control

PLACEBO COMPARATOR

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

silver diammine fluoride

EXPERIMENTAL

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

silver diammine fluoride and KI

ACTIVE COMPARATOR

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; Other: saturated potassium iodide solution

Interventions

silver diammine fluoride DRUG

topical application of the SDF solution onto tooth root surfaces

Also known as: SDF

silver diammine fluoride; silver diammine fluoride and KI

Water as placebo OTHER

topical application of water as a placebo in the control arm

Also known as: Water

control

saturated potassium iodide solution OTHER

topical application of SDF solution followed by KI solution onto tooth root surfaces

Also known as: KI

silver diammine fluoride and KI

Eligibility Criteria

• Age: 56 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 30938645 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride; Water

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof. E.C.M. Lo
• Organization: University of Hong Kong

edward-lo@hku.hk

852-2859 0292

Study Officials

• Edward CM Lo, BDS, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: February 10, 2015
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)