Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777968
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2021-02-26
Brief Title:
Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation Of Fluoride Uptake By Dentine Following Pretreatment With Silver Diamine Fluoride And Potassium Iodide Under Resin Modified Glass Ionomer Restoration Versus Resin Modified Glass Ionomer Restoration Alone In Carious Primary Molars In Vitro Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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 one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years it was found that 614 of these children had dental caries In order to avoid serious complications of untreated dental caries such as pain infections emergency visits and possibly hospitalization an effective low cost treatment should be identified particularly in areas with poor dental access
Studies have proven that silver diamine fluoride SDF is a topical fluoride that has the ability to effectively arrest and prevent dental caries
Studies have proven that silver diamine fluoride SDF is a topical fluoride that has the ability to effectively arrest and prevent dental caries
Detailed Description:
It was concluded that fluoride uptake into dentine from conventional GI restorations was not affected in the presence of SDF and KI It was also mentioned that the results may be different if conditioning is applied not etching and recommended this for future investigation
Aim Therefore the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide KI prior to placing resin modified glass ionomer RMGI restorations will affect the fluoride uptake into primary dentine or not
Study Setting
The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Cairo University Egypt
Energy Dispersive X-ray analysis with Scanning Electron Microscope SEMEDX measurement analysis was conducted at the National Research Center NRC Egypt
Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department Faculty of Dentistry Cairo University at the end of every day
Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant Isomet 4000 USA forming two similar halves so that the 20 molars were sectioned to 40 halves
Each tooth was placed in a separate container with its 2 halves
Teeth containers were then randomly allocated either to the control or intervention group
Control Group One half empty and the other half with Resin Modified Glass Ionmer RMGI only
Intervention Group One half empty and the other half SDFKIRMGI
After dehydration teeth were mounted on stubs using double-sided carbon tape and sputter coated with gold for 20 s using a Turbo molecular pumped coater QUORUM 150T ES Laughton United Kingdom
Teeth were then placed in SEMEDX for fluoride measurement by weight percentage
Data showed parametric distribution so it was represented by mean and standard deviation SD values Independent and paired t-tests were used for inter and intragroup comparisons respectively The significance level was set at p 005 within all tests Statistical analysis was performed with R statistical analysis software version 403 for windows R Core Team 2020
Aim Therefore the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide KI prior to placing resin modified glass ionomer RMGI restorations will affect the fluoride uptake into primary dentine or not
Study Setting
The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Cairo University Egypt
Energy Dispersive X-ray analysis with Scanning Electron Microscope SEMEDX measurement analysis was conducted at the National Research Center NRC Egypt
Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department Faculty of Dentistry Cairo University at the end of every day
Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant Isomet 4000 USA forming two similar halves so that the 20 molars were sectioned to 40 halves
Each tooth was placed in a separate container with its 2 halves
Teeth containers were then randomly allocated either to the control or intervention group
Control Group One half empty and the other half with Resin Modified Glass Ionmer RMGI only
Intervention Group One half empty and the other half SDFKIRMGI
After dehydration teeth were mounted on stubs using double-sided carbon tape and sputter coated with gold for 20 s using a Turbo molecular pumped coater QUORUM 150T ES Laughton United Kingdom
Teeth were then placed in SEMEDX for fluoride measurement by weight percentage
Data showed parametric distribution so it was represented by mean and standard deviation SD values Independent and paired t-tests were used for inter and intragroup comparisons respectively The significance level was set at p 005 within all tests Statistical analysis was performed with R statistical analysis software version 403 for windows R Core Team 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None