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Completed

NCT Number: NCT02360124

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

56 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

silver diammine fluoride

Drug

topical application of the SDF solution onto tooth root surfaces

Other names: SDF

Water as placebo

Other

topical application of water as a placebo in the control arm

Other names: Water

saturated potassium iodide solution

Other

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

Other names: KI

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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