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Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults

NCT04255251 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-05

No results posted yet for this study

Summary

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.

Conditions

  • Caries Roots
  • Flouride Varnish
  • Caries; Dentin
  • Caries Arrested

Interventions

DRUG

Silver Diammine Fluoride

Subjects will receive SDF around their crown margins every 6 months for next 3 years.

DRUG

Fluoride Varnishes

Subjects will receive SDF around their crown margins every 6 months for next 3 years.

Sponsors & Collaborators

  • University of New England

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-26
Primary Completion
2023-01-03
Completion
2024-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255251 on ClinicalTrials.gov