Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

EQUIA

Gradia Direct Posterior

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring glass ionomer, composite resin

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

a need for at least two but not more than four posterior toothcolored restorations;
the presence of teeth to be restored in occlusion;
teeth that were symptomless and vital;
a normal periodontal status;
a good likelihood of recall availability.

Exclusion Criteria:

partly erupted teeth;
absence of adjacent and antagonist teeth
poor periodontal status;
adverse medical history;
potential behavioral problems.

Sites / Locations

Hacettepe University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

EQUIA

Gradia Direct Posterior

Arm Description

EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.

Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.

Outcomes

Primary Outcome Measures

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable)

marginal discoloration

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction

retention rate

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed

anatomic form

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.

color change

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change. Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency

Secondary Outcome Measures

Full Information

NCT ID

NCT03822403

First Posted

January 28, 2019

Last Updated

January 28, 2019

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT03822403

Brief Title

Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation

Official Title

Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2009 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 9 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).

Detailed Description

Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti- cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

glass ionomer, composite resin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double (Participant, Investigator)

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EQUIA

Arm Type

Active Comparator

Arm Description

EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.

Arm Title

Gradia Direct Posterior

Arm Type

Active Comparator

Arm Description

Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.

Intervention Type

Device

Intervention Name(s)

EQUIA

Other Intervention Name(s)

Glass ionomer restorative system

Intervention Description

Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.

Intervention Type

Device

Intervention Name(s)

Gradia Direct Posterior

Other Intervention Name(s)

Micro hybrid composite

Intervention Description

The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.

Primary Outcome Measure Information:

Title

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation

Description

Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable)

Time Frame