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Class II Restorations With High-Filled Flowable Composites

Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06346795
Enrollment
60
Registered
2024-04-04
Start date
2024-06-01
Completion date
2025-06-01
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Dental Caries, Dental Caries

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).

Interventions

OTHERHigh-filling flowable dental composite

Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

A patient presenting with; 1. over 18 years of age 2. a normal periodontal status and good general health 3. proximal caries that are similar in size to premolar and molar teeth 4. vital teeth 5. teeth in contact with the opposing tooth and subjected to normal occlusal forces 6. attend follow-up appointments

Exclusion criteria

1. poor oral hygiene status 2. those with severe or chronic periodontitis 3. absence of adjacent and antagonist teeth 4. potential behavioral problems (e.g. bruxism) 5. allergy to any product used in the study 6. exposure of the pulp during cavity preparation 7. systemically unhealthy 8. pregnant and lactating women

Design outcomes

Primary

MeasureTime frameDescription
Retention7th day, 6th month, 12th month.No loss of restorative material
Color match7th day, 6th month, 12th month.The restoration matches the adjacent tooth structure in color and translucency
Marginal discoloration7th day, 6th month, 12th month.There is no discoloration anywhere on the margin between the restoration and the tooth structure
Marginal adaptation7th day, 6th month, 12th month.There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Secondary caries7th day, 6th month, 12th month.No evidence of secondary caries
Surface texture7th day, 6th month, 12th month.The surface of the restoration does not have any defects
Anatomical form7th day, 6th month, 12th month.The restoration is continuous with the existing anatomic form
Postoperative sensitivity7th day, 6th month, 12th month.No postoperative sensitivity, after the restorative procedure and during the study

Countries

Turkey (Türkiye)

Contacts

Primary ContactMERVE GÜRSES
merve.gurses@selcuk.edu.tr+905313747997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026