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

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ClinicalTrials.gov Identifier: NCT04255251
Recruitment Status : Unknown
Verified October 2021 by Shaista Rashid, University of New England.
Recruitment status was:  Recruiting
First Posted : February 5, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Shaista Rashid, University of New England

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Caries Roots Flouride Varnish Caries; Dentin Caries Arrested Drug: Silver Diammine Fluoride Drug: Fluoride Varnishes Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
Masking: Double (Participant, Investigator)
Masking Description:

Participants will not know which type of fluoride they are getting around their crow margins.

Principal investigator will measuring the extend of the decay does not know about the type of fluoride treatment patient got.
Primary Purpose: Prevention
Official Title: Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Actual Study Start Date : June 26, 2021
Estimated Primary Completion Date : January 3, 2023
Estimated Study Completion Date : January 3, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255251


Contacts
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Contact: Shaista Rashid, B.D.S, M.S. 2072214861 srashid2@une.edu
Contact: Mohamed ElSalhy, MPH, PHD 2072214862 melsalhy@une.edu

Locations
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United States, Maine
University of New England Recruiting
Portland, Maine, United States, 04101
Contact: SHAISTA RASHID, D.D.S    207-221-4861    srashid2@une.edu   
Sponsors and Collaborators
University of New England
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Shaista Rashid, Assistant Clinical Professor, University of New England
ClinicalTrials.gov Identifier: NCT04255251    
Other Study ID Numbers: Universityof New Engalnd
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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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
Additional relevant MeSH terms:
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Root Caries
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Dental Caries
Tooth Demineralization
Tooth Diseases
 Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs