Phase 3 N=323 Randomized Double-blind Prevention

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

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT02360124 ↗

Enrolled (actual)

323

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Number of New Tooth Root Caries Lesions — 1.1; 0.43; 0.56 new carious root surfaces

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: silver diammine fluoride (Drug); Water as placebo (Other); saturated potassium iodide solution (Other)
Age: Adult, Older Adult · 56+ yrs
Sex: All
Sponsor: The University of Hong Kong
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of New Tooth Root Caries Lesions	1.1; 0.43; 0.56	—
SECONDARY Proportion of Inactive Root Caries Lesions	45.0; 90.0; 92.5	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02360124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.