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

NCT05744622 | Completed

• 1 other identifier: 431/2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

High Caries Risk Patients

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap)

EXPERIMENTAL

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

Ketac Universal Aplicap enhanced with light-emitting diode radiant heat

EXPERIMENTAL

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

Interventions

KetacTM Universal AplicapTM OTHER

chemically cured conventional GICs

chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap)

KetacTM Universal AplicapTM with light cure OTHER

chemically cured conventional GICs with light curing enhancement

Ketac Universal Aplicap enhanced with light-emitting diode radiant heat

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of dentistry, Suez Canal university

Ismailia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer operative dentistry department

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: February 20, 2021
• Primary Completion: February 20, 2022
• Study Completion: May 22, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)