Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04255251
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2020-01-29
Brief Title:
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Sponsor:
University of New England
Organization:
University of New England
Study Overview
Official Title:
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lesionThe 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
Prevention becomes an area of paramount importance Many studies have advocated nonsurgical intervention for shallow dentin caries lesionThe 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None