Heated Glass Ionomer Cement in Primary Molars
Primary Purpose
Dental Caries, Glass-Ionomer Cement, Primary Teeth
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glass -Ionomer Cement with /without Led Light Cure
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Subject is mentally and systemically healthy
- Subject has at least two approximal carious lesions at both sides of jaws
- Subject has a normal occlusal relationship with natural dentition
- Subject has at least one adjacent tooth contact
Exclusion Criteria:
- Subject has history of bruxism,
- Subject has allergies to ingredients of glass ionomer based restorative materials.
- Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
- Subject has abrasion, erosion, abfraction,
- Subject has fistula, abscess or pathological mobility,
- Subject has pain, pulp exposure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-Heated Arm
Heated Arm
Arm Description
Proximal cavities were restored with Equia Forte (GC Corporation, Europe) according to manufacturer's orders.
Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.
Outcomes
Primary Outcome Measures
Clinical success assessment measurement
All restorations were evaluated by using Modified US Public Health Service criteria (modified USPHS criteria). Marginal Integrity (MI)), Marginal Discoloration (MD), Secondary Caries (SC), Anatomic Form (AF), and retention (R) were evaluated. A restoration was considered a failure when codes Charlie (C) and D (Delta) were registered. Codes A (Alpha) and B (Bravo) was considered a success or acceptable. follow up period was baseline, 6th months, 12th months.
Secondary Outcome Measures
Full Information
NCT ID
NCT04291872
First Posted
February 17, 2020
Last Updated
February 28, 2020
Sponsor
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT04291872
Brief Title
Heated Glass Ionomer Cement in Primary Molars
Official Title
Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars: 12 Months Follow Up
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 and/or 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 mW/cm2, 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, Fisher's 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 < 0.05 was considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Glass-Ionomer Cement, Primary Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Heated Arm
Arm Type
Experimental
Arm Description
Proximal cavities were restored with Equia Forte (GC Corporation, Europe) according to manufacturer's orders.
Arm Title
Heated Arm
Arm Type
Experimental
Arm Description
Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.
Intervention Type
Other
Intervention Name(s)
Glass -Ionomer Cement with /without Led Light Cure
Intervention Description
Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.
Primary Outcome Measure Information:
Title
Clinical success assessment measurement
Description
All restorations were evaluated by using Modified US Public Health Service criteria (modified USPHS criteria). Marginal Integrity (MI)), Marginal Discoloration (MD), Secondary Caries (SC), Anatomic Form (AF), and retention (R) were evaluated. A restoration was considered a failure when codes Charlie (C) and D (Delta) were registered. Codes A (Alpha) and B (Bravo) was considered a success or acceptable. follow up period was baseline, 6th months, 12th months.
Time Frame
12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is mentally and systemically healthy
Subject has at least two approximal carious lesions at both sides of jaws
Subject has a normal occlusal relationship with natural dentition
Subject has at least one adjacent tooth contact
Exclusion Criteria:
Subject has history of bruxism,
Subject has allergies to ingredients of glass ionomer based restorative materials.
Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
Subject has abrasion, erosion, abfraction,
Subject has fistula, abscess or pathological mobility,
Subject has pain, pulp exposure
12. IPD Sharing Statement
Learn more about this trial
Heated Glass Ionomer Cement in Primary Molars
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