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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
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 17, 2020
    Last Updated
    February 28, 2020
    Sponsor
    Marmara University
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    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

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    Heated Glass Ionomer Cement in Primary Molars

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