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

NCT ID: NCT05744622

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2022-05-22

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

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.

Conditions

High Caries Risk Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

KetacTM Universal AplicapTM

Intervention Type: OTHER

chemically cured conventional GICs

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

Group Type: EXPERIMENTAL

KetacTM Universal AplicapTM with light cure

Intervention Type: OTHER

chemically cured conventional GICs with light curing enhancement

Interventions

KetacTM Universal AplicapTM

chemically cured conventional GICs

Intervention Type: OTHER

KetacTM Universal AplicapTM with light cure

chemically cured conventional GICs with light curing enhancement

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

eman awad

Assistant lecturer operative dentistry department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry, Suez Canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

431/2021

Identifier Type: -

Identifier Source: org_study_id