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NCT Number: NCT06346756

Clinical Evaluation of Class II Restorations

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).

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Key information

Conditions

Dental Caries Dental Caries Class II Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Treatment of dental caries.

Other

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.

Primary outcomes

  1. Retention

    Time frame: seventh day, sixth month, twelfth month

    No loss of restorative material

Secondary outcomes

  1. color match

    Time frame: seventh day, sixth month, twelfth month

    The restoration matches the adjacent tooth structure in color and translucency

  2. marginal adaptation

    Time frame: seventh day, sixth month, twelfth month

    There is no visible evidence of a crevice along the margin into which the explorer will penetrate

  3. marginal discoloration

    Time frame: seventh day, sixth month, twelfth month

    There is no discoloration anywhere on the margin between the restoration and the tooth structure

  4. surface texture

    Time frame: seventh day, sixth month, twelfth month

    The surface of the restoration does not have any defects

  5. anatomical form

    Time frame: seventh day, sixth month, twelfth month

    The restoration is continuous with the existing anatomic form

  6. secondary caries

    Time frame: seventh day, sixth month, twelfth month

    No evidence of secondary caries

  7. postoperative sensitivity

    Time frame: seventh day, sixth month, twelfth month

    No postoperative sensitivity, after the restorative procedure and during the study

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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