Clinical Trial: Non-invasive Treatment of Root Caries in Older Adults

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults

Brief Summary:

This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.

Follow-up will be carries out every 6 months for two years to assess:

  • Root caries incidence.
  • Lesion arresting
  • Changes in salivary flow
  • Microbiology pattern shift
  • Variations in oral health- related quality of life by OHIP-14 Sp

Detailed Summary:

Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.

Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.

Methodology. A double blind randomized controlled trial (RCT) on indepe
Sponsor: University of Talca

Current Primary Outcome: Root caries incidence by the Root Caries Index (RCI) expressed as percentage. [ Time Frame: Every 6 months up to 3 years ]

Root caries on exposed root surfaces will be assessed every 6 months and expressed as changes in the Root Caries Index. To calculate, the following formula is used: (Decayed surfaces+ Surfaces with fillings / decayed surfaces +surfaces with fillings + Sound surfaces *100)


Original Primary Outcome: Root caries incidence by the Root Caries Index (RCI) expressed as percentage. [ Time Frame: Up to 3 years ]

Root caries on exposed root surfaces will be assessed every 6 months and expressed as changes in the Root Caries Index. To calculate, the following formula is used: (Decayed surfaces+ Surfaces with fillings / decayed surfaces +surfaces with fillings + Sound surfaces *100)


Current Secondary Outcome:

  • Oral Health related quality of life, measured by the Oral Health Impact Profile (OHIP-14 Sp) [ Time Frame: Anually, up to 3 years ]
    The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group.
  • Microbiology - recovered CFU/biofilm from the root surface biofilm. [ Time Frame: At 6 months from the beginning of the study. ]
    Changes in the microbial profile on the root caries lesions will be determined by plate culturing of total streptococci, Streptococcus mutans, Streptococcus sanguinis and Lactobacilli spp.
  • Root caries inactivation - Percentage of lesions that changed from active to inactive (arrested) [ Time Frame: Every 6 months up to 3 years ]
    Active lesions will be examined every 6 months to determine whether they were arrested by the fluoridated toothpaste. These data will be expressed as %Active root caries (%ARC)
  • Salivary flow - Unstimulated and Stimulated salivary flow in mL per min. [ Time Frame: Anually up to 3 years ]
    Changes in the salivary flow upon fluoride toothpaste usage will be monitored over time every 6 months.


Original Secondary Outcome:

  • Oral Health related quality of life, measured by the Oral Health Impact Profile (OHIP-14 Sp) [ Time Frame: Up to 3 years ]
    The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group.
  • Microbiology - recovered CFU/biofilm from the root surface biofilm. [ Time Frame: Up to 1 year ]
    Changes in the microbial profile on the root caries lesions will be determined by plate culturing of total streptococci, Streptococcus mutans, Streptococcus sanguinis and Lactobacilli spp.
  • Root caries inactivation - Percentage of lesions that changed from active to inactive (arrested) [ Time Frame: Up to 4 years ]
    Active lesions will be examined every 6 months to determine whether they were arrested by the fluoridated toothpaste. These data will be expressed as %Active root caries (%ARC)
  • Salivary flow - Unstimulated and Stimulated salivary flow in mL per min. [ Time Frame: Up to 1 year ]
    Changes in the salivary flow upon fluoride toothpaste usage will be monitored over time every 6 months.


Information By: University of Talca

Dates:
Date Received: December 7, 2015
Date Started: July 2014
Date Completion: December 2017
Last Updated: January 5, 2016
Last Verified: January 2016