Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04291872
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2020-02-17
Brief Title:
Heated Glass Ionomer Cement in Primary Molars
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars 12 Months Follow Up
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Objective The aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement GIC restorations in primary molars
Material Method This randomized split mouth multicenter study was performed in four different centers including 88 patients aged between 5-7 years old Selection criteria included clinically andor radiographically detected proximal caries extending into the dentin tissue A total of 250 primary molars were restored with a bulk fill GIC Equia Forte GC Europe and randomly allocated to one of the following groups 1 non-heated n 125 and 2 heated n 125 LED light GC- D-Light DUO Tokyo Japan was used at standard mode 1200 mWcm2 at 50-60 ºC for 60 sec for heat application All restorations were clinically evaluated using modified USPHS criteria at the baseline 6 months and 12 months Chi-square test Fishers Exact Chi-square test Continuity Yates correction Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods frequency Kaplan Meier and Life Tables were used for survival analysis P value 005 was considered statistically significant
Material Method This randomized split mouth multicenter study was performed in four different centers including 88 patients aged between 5-7 years old Selection criteria included clinically andor radiographically detected proximal caries extending into the dentin tissue A total of 250 primary molars were restored with a bulk fill GIC Equia Forte GC Europe and randomly allocated to one of the following groups 1 non-heated n 125 and 2 heated n 125 LED light GC- D-Light DUO Tokyo Japan was used at standard mode 1200 mWcm2 at 50-60 ºC for 60 sec for heat application All restorations were clinically evaluated using modified USPHS criteria at the baseline 6 months and 12 months Chi-square test Fishers Exact Chi-square test Continuity Yates correction Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods frequency Kaplan Meier and Life Tables were used for survival analysis P value 005 was considered statistically significant
Detailed Description:
None
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