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

October 3, 2021 updated by: Shaista Rashid, University of New England

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

  1. DIAGOdent:
  2. Tectile exam:

The procedures of every clinical appointments will be as following:

First appointment:

Visit will include

  • Health history
  • Caries risk assessment
  • Clinical exam (DIAGNOdent, tactile) (described above)
  • Radiograph (described above)
  • Subject will sigh consent form
  • Treatment group will receive SDF
  • Control group will receive Fluoride varnish

Second visit (6 month from the first appointment ):

Visit will include

  • Health history retake
  • Caries risk assessment retake
  • New Clinical exam (DIAGNOdent, tactile)
  • New Radiograph
  • Subject will receive his or her treatment according to their allocation

Third visit (12 month from the first appointment ):

Visit will include

  • Health history retake
  • Caries risk assessment retake
  • New Clinical exam (DIAGNOdent, tactile)
  • New Radiograph
  • Subject will receive his or her treatment according to their allocation

Third visit (12 month from the first appointment ):

Visit will include

  • Health history retake
  • Caries risk assessment retake
  • New Clinical exam (DIAGNOdent, tactile)
  • New Radiograph
  • Subject will receive his or her treatment according to their allocation

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shaista Rashid, B.D.S, M.S.
  • Phone Number: 2072214861
  • Email: srashid2@une.edu

Study Contact Backup

  • Name: Mohamed ElSalhy, MPH, PHD
  • Phone Number: 2072214862
  • Email: melsalhy@une.edu

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04101
        • Recruiting
        • University of New England
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-85 years old with crown/bridges
  • Open crown margins
  • Decay present around crown margins
  • Pt is not intention to go with the conventiontial restorative treatment to replace the crown for any reason
  • Subjects who can do the follow up for at least one year

Exclusion Criteria:

  • Teeth with periapical lesion
  • Teeth which have pain to percussion
  • Subjects who have silver or fluoride allergy
  • Subjects who have gingivitis
  • Subjects who have stomatitis
  • Subjects who have tooth mobility
  • Subjects who have furcation involvement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
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 will receive SDF around their crown margins every 6 months for next 3 years.
ACTIVE_COMPARATOR: Fluoride varnish group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tactile exam to evaluate extend of caries around tooth margin
Time Frame: Every 6 month for next 3 years

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
Every 6 month for next 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIAGOdent: laser fluorescence to aid in the detection of caries
Time Frame: Every 6 month for next 3 years
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
Every 6 month for next 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2021

Primary Completion (ANTICIPATED)

January 3, 2023

Study Completion (ANTICIPATED)

January 3, 2024

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 3, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universityof New Engalnd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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