An Early Phase 1 interventional study of Silver Diammine Fluoride and Fluoride Varnishes in Caries Roots, Flouride Varnish and Caries; Dentin, sponsored by University of New England. Status unknown at 1 site in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by University of New England · Early Phase 1, Interventional, and Prevention
Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 .
Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.
Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.
Clinical exam will include the following
The procedures of every clinical appointments will be as following:
First appointment:
Visit will include
Second visit (6 month from the first appointment ):
Visit will include
Third visit (12 month from the first appointment ):
Visit will include
Third visit (12 month from the first appointment ):
Visit will include
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 200 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →University of New England is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.
Drug: Silver Diammine Fluoride
Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.
Drug: Fluoride Varnishes
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
Tactile exam to evaluate extend of caries around tooth margin
WHO ball end probe will be used to detect cavities around the restoration margins. Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine
Time frame: Every 6 month for next 3 years
DIAGOdent: laser fluorescence to aid in the detection of caries
As the incident laser light is dispersed into the site, carious tooth structure will exhibit fluorescence, proportionate to the degree of caries, resulting in elevated scale readings on the display. Healthy tooth structure exhibits little or no fluorescence and will result in very low scale readings on the display. Over 90% accurate in detecting lesions not detectable with an explorer or bitewing X-rays. The remote display for DIAGNOdent pen uses infra-red signals, and the values are shown simultaneously on the DIAGNOdent pen and on the remote display
Time frame: Every 6 month for next 3 years
Started Jun 2021 (actual). Primary completion is estimated for Jan 2023, 18 months after the start.
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Silver diamine fluoride
University of New England