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Clinical Performance of Glass-hybrid in the Treatment of Class III Restorations (Class-III)

Primary Purpose

Class III Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Equia forte HT
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Dental Caries focused on measuring Glass hybrid restorative, Class III, Anterior restoration, FDI criteria

Eligibility Criteria

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

Inclusion Criteria: The participant must be at least 18 years of age or older The participant has at least two class III lesions and the lesions are in symmetrical teeth located in the right and left arch The lesion covers at most 2/3 and at least 1/3 of the dentin Participant voluntarily signing the informed consent form The participant does not have a physical disability that may prevent them from coming to the control. Absence of a periapical pathology in the involved tooth Exclusion Criteria: Having systemic disorders that may prevent the participant from regularly attending treatment and control appointments. Having severe periodontal problems in the tooth planned to be treated Absence of the opposite of the tooth and not participating in chewing Lesions which is limited with the enamel tissue Teeth with lesions that are too large to be restored Patients with anterior malocclusion Patients with parafunctional habits. Mentally disabled patients.

Sites / Locations

  • Hacettepe University School of DentistryRecruiting
  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Equia forte HT (glass-hybrid) group

"G-Aenial anterior"

Arm Description

This study planned to investigate the clinical performance of Equia Forte HT (permanent glass hybrid restorative) in the treatment of anterior class III restorations. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties.

This group will serve as a "control". Equia forte HT (glass-hybrid) restorations will compare with the "G-Aenial anterior" anterior resin composite restorations.

Outcomes

Primary Outcome Measures

Functional properties
The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The functional properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Esthetic properties
Second outcome is esthetic properties. The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
May 2, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05843734
Brief Title
Clinical Performance of Glass-hybrid in the Treatment of Class III Restorations
Acronym
Class-III
Official Title
Clinical Performance of Glass Hybrid Restorations in the Treatment of Class III Lesions: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

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
No

5. Study Description

Brief Summary
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in class III lesions. The lesions will be restored with glass hybrid restorative (Equia Forte) or anterior composite resin (G-aenial Anterior). Restorations will be evaluated after 24 months according to FDI criteria and the data will be analyzed.
Detailed Description
The aim of this study was to comparatively evaluate the clinical performance of a glass-hybrid-restorative with an anterior composite resin (G-aenial Anterior) in class III lesions. Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for class III lesions on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 100 upper incisors of 50 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches. The "split-mouth" model will be used in the study, with two teeth included in one mouth and each restorative material placed in one tooth. The restorative material to be placed on the teeth will be determined randomly. Before starting the restoration, papers with the names of both materials will be placed in envelopes, and then the assistant staff will be asked to randomly select one of the envelopes during the restoration stage to provide randomization.Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Dental Caries
Keywords
Glass hybrid restorative, Class III, Anterior restoration, FDI criteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Equia forte HT (glass-hybrid) group
Arm Type
Experimental
Arm Description
This study planned to investigate the clinical performance of Equia Forte HT (permanent glass hybrid restorative) in the treatment of anterior class III restorations. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties.
Arm Title
"G-Aenial anterior"
Arm Type
Active Comparator
Arm Description
This group will serve as a "control". Equia forte HT (glass-hybrid) restorations will compare with the "G-Aenial anterior" anterior resin composite restorations.
Intervention Type
Procedure
Intervention Name(s)
Equia forte HT
Other Intervention Name(s)
G-Aenial anterior
Intervention Description
Restoration of anterior class III caries lesions
Primary Outcome Measure Information:
Title
Functional properties
Description
The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The functional properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Time Frame
2 years
Title
Esthetic properties
Description
Second outcome is esthetic properties. The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The participant must be at least 18 years of age or older The participant has at least two class III lesions and the lesions are in symmetrical teeth located in the right and left arch The lesion covers at most 2/3 and at least 1/3 of the dentin Participant voluntarily signing the informed consent form The participant does not have a physical disability that may prevent them from coming to the control. Absence of a periapical pathology in the involved tooth Exclusion Criteria: Having systemic disorders that may prevent the participant from regularly attending treatment and control appointments. Having severe periodontal problems in the tooth planned to be treated Absence of the opposite of the tooth and not participating in chewing Lesions which is limited with the enamel tissue Teeth with lesions that are too large to be restored Patients with anterior malocclusion Patients with parafunctional habits. Mentally disabled patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UZAY Koç VURAL, PhD. DDS
Phone
+90 5072122626
Email
uzaykoc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
UZAY Koç VURAL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UZAY Koç VURAL, PhD.DDS
Organizational Affiliation
Hacettepe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University School of Dentistry
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uzay Koc vural, PhD. DDS
Phone
+90 5072122626
Email
uzaykoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Esra Ergin, PhD. DDS
First Name & Middle Initial & Last Name & Degree
Cansu Atalay, PhD. DDS
First Name & Middle Initial & Last Name & Degree
Sevil Gurgan, PhD. DDS
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uzay Koc vural, PhD. DDS
Phone
+90 5072122626
Email
uzaykoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Esra Ergin, PhD. DDS
First Name & Middle Initial & Last Name & Degree
Cansu Atalay, PhD. DDS
First Name & Middle Initial & Last Name & Degree
Sevil Gurgan, PhD. DDS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Performance of Glass-hybrid in the Treatment of Class III Restorations

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