Class II Restorations With High-Filled Flowable Composites
Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins
1 other identifier
interventional
60
1 country
1
Brief Summary
In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 25, 2024
April 1, 2024
6 months
March 29, 2024
April 24, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
Retention
No loss of restorative material
7th day, 6th month, 12th month.
Color match
The restoration matches the adjacent tooth structure in color and translucency
7th day, 6th month, 12th month.
Marginal discoloration
There is no discoloration anywhere on the margin between the restoration and the tooth structure
7th day, 6th month, 12th month.
Marginal adaptation
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
7th day, 6th month, 12th month.
Secondary caries
No evidence of secondary caries
7th day, 6th month, 12th month.
Surface texture
The surface of the restoration does not have any defects
7th day, 6th month, 12th month.
Anatomical form
The restoration is continuous with the existing anatomic form
7th day, 6th month, 12th month.
Postoperative sensitivity
No postoperative sensitivity, after the restorative procedure and during the study
7th day, 6th month, 12th month.
Study Arms (3)
G-aenial Universal Injectable
EXPERIMENTALGrandio Flow
EXPERIMENTALClearfil Majesty Flow
EXPERIMENTALInterventions
Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.
Eligibility Criteria
You may qualify if:
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- proximal caries that are similar in size to premolar and molar teeth
- vital teeth
- teeth in contact with the opposing tooth and subjected to normal occlusal forces
- attend follow-up appointments
You may not qualify if:
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
- exposure of the pulp during cavity preparation
- systemically unhealthy
- pregnant and lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merve Gürses
Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry
Central Study Contacts
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 Proffesor
Study Record Dates
First Submitted
March 29, 2024
First Posted
April 4, 2024
Study Start
June 1, 2024
Primary Completion
December 1, 2024
Study Completion
June 1, 2025
Last Updated
April 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share