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

High Caries Risk Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05744622
• Other study ID #: 431/2021
• Status: Completed
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: May 22, 2022

Study information

• Verified date: February 2023
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 22, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Caries Risk Patients

Intervention

Other:
• KetacTM Universal AplicapTM
chemically cured conventional GICs
• KetacTM Universal AplicapTM with light cure
chemically cured conventional GICs with light curing enhancement

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, Suez Canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of biological properties	Clinical performance of biological properties according to FDI criteria	12 months
Primary	Clinical performance of Functional properties	Clinical performance of Functional properties according to FDI criteria	12 months