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

Primary Purpose

Caries Roots, Flouride Varnish, Caries; Dentin

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Silver Diammine Fluoride
Fluoride Varnishes
Sponsored by
University of New England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries Roots

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of New EnglandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Fluoride varnish group

Arm Description

Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.

Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2020
Last Updated
October 3, 2021
Sponsor
University of New England
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1. Study Identification

Unique Protocol Identification Number
NCT04255251
Brief Title
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Official Title
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2021 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New England

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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 DIAGOdent: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Roots, Flouride Varnish, Caries; Dentin, Caries Arrested

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.
Arm Title
Fluoride varnish group
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.
Intervention Type
Drug
Intervention Name(s)
Silver Diammine Fluoride
Intervention Description
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
Intervention Type
Drug
Intervention Name(s)
Fluoride Varnishes
Intervention Description
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
Primary Outcome Measure Information:
Title
Tactile exam to evaluate extend of caries around tooth margin
Description
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
Secondary Outcome Measure Information:
Title
DIAGOdent: laser fluorescence to aid in the detection of caries
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaista Rashid, B.D.S, M.S.
Phone
2072214861
Email
srashid2@une.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed ElSalhy, MPH, PHD
Phone
2072214862
Email
melsalhy@une.edu
Facility Information:
Facility Name
University of New England
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHAISTA RASHID, D.D.S
Phone
207-221-4861
Email
srashid2@une.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
28888414
Citation
Giusti L, Steinborn C, Steinborn M. Use of silver diamine fluoride for the maintenance of dental prostheses in a high caries-risk patient: A medical management approach. J Prosthet Dent. 2018 May;119(5):713-716. doi: 10.1016/j.prosdent.2017.06.007. Epub 2017 Sep 6.
Results Reference
background
PubMed Identifier
31299955
Citation
Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
Results Reference
result

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

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