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

Dental Caries Clinical Trial

Official title:

Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360124
• Other study ID #: UW11-120
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 17, 2014
• Last updated: February 4, 2015
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: February 2015
• Source: The University of Hong Kong
• Contact: Edward CM Lo, BDS, PhD
• Phone: 852-28590292
• Email: edward-lo[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 323
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• silver diammine fluoride
topical application of the SDF solution onto tooth root surfaces

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 months	No
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	30 months	No