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

• Sponsor: Suez Canal University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05744622
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
High Caries Risk Patients	Other: KetacTM Universal AplicapTM; Other: KetacTM Universal AplicapTM with light cure	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement: A Randomized Controlled Clinical Trial
• Actual Study Start Date: Feb 20, 2021
• Actual Primary Completion Date: Feb 20, 2022
• Actual Study Completion Date: May 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical performance of biological properties [12 months]

   Clinical performance of biological properties according to FDI criteria

2. Clinical performance of Functional properties [12 months]

   Clinical performance of Functional properties according to FDI criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry, Suez Canal university	Ismailia		Egypt

Sponsors and Collaborators

• Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: eman awad, Assistant lecturer operative dentistry department, Suez Canal University
• ClinicalTrials.gov Identifier: NCT05744622
• Other Study ID Numbers: 431/2021
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 27, 2023