Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement

Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement: A Randomized Controlled Clinical Trial

Introduction:

Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites.

Aim:

Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .

Methodology:

Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated at 4 time points

Study Overview

• Status: Completed
• Conditions: High Caries Risk Patients
• Intervention / Treatment: Other: KetacTM Universal AplicapTM; Other: KetacTM Universal AplicapTM with light cure

Detailed Description

Introduction:

Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites. Various techniques have been suggested to improve properties of conventional GICs such as radiant heat transfer by Light Emitting Diode (LED) or lasers, ultrasonic energy transfer also using of (CaCl2) solution.

Aim:

Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .

Methodology:

Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated immediately after restoration (T0), six months later (T1), and after 12 months (T2) using Federation Dentaire International (FDI) criteria for assessment of dental restorations.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of dentistry, Suez Canal university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age group 21 - 45 years.
2. Both males and females will be included.
3. Ability to return for periodic follow-up (good general health).
4. Only co-operative patients.
5. Vital upper or lower carious posterior teeth.

Exclusion Criteria:

1. Teeth with any pathologic pulpal disease.
2. Teeth with previous restorations
3. Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
4. Patients with severe or chronic periodontitis.
5. Patients have allergy to the materials used in this trial. 6- Nonfunctioning teeth with no opposing dentition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap); For restoration of M1 group, capsule activation will be performed through loading of the KetacTM Universal AplicapTM GIC capsule into its activator keeping the applicator nozzle closed, using the ball of my hand to depress the activator lever firmly as far as it will go and hold it down for 2 to 4 seconds. Then the capsule will be mixed in a high frequency mixing device for 8 seconds. The mixed capsule will be immediately removed from the mixer and loaded into the AplicapTM Applier then application nozzle will be opened to extrude the mixture directly into the preparation as a single bulk within 1:40 minute. The preliminary contour will be done using a ball burnisher.	Other: KetacTM Universal AplicapTM; chemically cured conventional GICs
Experimental: Ketac Universal Aplicap enhanced with light-emitting diode radiant heat; Restoration of M2 group will be performed following the same steps which will be carried out for M1 group but the achieved restorations will be enhanced by light-emitting diode radiant heat for 60 seconds	Other: KetacTM Universal AplicapTM with light cure; chemically cured conventional GICs with light curing enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of biological properties	Clinical performance of biological properties according to FDI criteria	12 months
Clinical performance of Functional properties	Clinical performance of Functional properties according to FDI criteria	12 months

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): May 22, 2022

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 431/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No