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Clinical Evaluation of Class II Restorations

Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06346756
Enrollment
71
Registered
2024-04-04
Start date
2023-01-01
Completion date
2023-07-15
Last updated
2024-06-05

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

Conditions

Dental Caries, Dental Caries Class II

Brief summary

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins. The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05).

Interventions

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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
Retentionseventh day, sixth month, twelfth monthNo loss of restorative material

Secondary

MeasureTime frameDescription
marginal adaptationseventh day, sixth month, twelfth monthThere is no visible evidence of a crevice along the margin into which the explorer will penetrate
marginal discolorationseventh day, sixth month, twelfth monthThere is no discoloration anywhere on the margin between the restoration and the tooth structure
surface textureseventh day, sixth month, twelfth monthThe surface of the restoration does not have any defects
color matchseventh day, sixth month, twelfth monthThe restoration matches the adjacent tooth structure in color and translucency
secondary cariesseventh day, sixth month, twelfth monthNo evidence of secondary caries
postoperative sensitivityseventh day, sixth month, twelfth monthNo postoperative sensitivity, after the restorative procedure and during the study
anatomical formseventh day, sixth month, twelfth monthThe restoration is continuous with the existing anatomic form

Countries

Turkey (Türkiye)

Outcome results

None listed

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