Skip to main content
OpenTrials
Completed

NCT Number: NCT06393270

5-year Clinical Follow-up of Restorative Materials

Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials.

The study was planned as an observational clinical trial. In the study, Class II restorations performed with Tetric Bulk Fill (TBF) and Filtek Bulk Fill (FBF) composites and Equia Forte Fil (EF) will be evaluated. Fifty-one patients and 119 restorations will be included in the study. Restorations will be assessed in terms of modified United States Public Health Service (USPHS) criteria during the 5th year. Cochran Q, Pearson chi-square, and Fisher-Freeman-Halton tests will be used for statistical analysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Who can participate

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

Inclusion criteria

  • Patients who were;
  • older than 18 years old
  • had good general health and oral hygiene
  • had interface restorations of similar size in their premolars and molars
  • were able to attend control appointments were included The teeth were determined as follows;

<!-- -->

  • in contact with the opposing tooth
  • exposed to normal occlusal forces on the dentition
  • restoration width not exceeding 1⁄2 of the intercuspal distance
  • normal response to vitality tests without periodontal pathology

Exclusion criteria

  • Patients with;
  • poor oral hygiene
  • those with active periodontal disease
  • those with severe bruxism
  • pregnant and lactating women
  • endodontically treated teeth were excluded from the study

Treatment and study plan

Modified US Public Health Service (USPHS) criteria

Diagnostic Test

Dental caries classification system

Primary outcomes

  1. Retention

    Time frame: 5th year.

    At the control appointment, it was determined whether there was material loss in the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

  2. Color Match

    Time frame: 5th year.

    At the control appointment, it was determined whether the restoration's color harmony with the adjacent tooth tissue was maintained. The scale used includes the characters A, B, and C. A is the best clinical result.

  3. Marginal Adaptation

    Time frame: 5th year.

    At the follow-up appointment, it was determined whether there was any deterioration in the marginal adaptation of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

  4. Marginal Discoloration

    Time frame: 5th year.

    At the control appointment, it was determined whether there was any color change at the edges of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

  5. Secondary Caries

    Time frame: 5th year.

    At the follow-up appointment, it was determined whether there was any decay under the restoration. The scale used includes the characters A and C. A is the best clinical result.

  6. Surface Texture

    Time frame: 5th year.

    At the control appointment, it was determined whether the restoration surface had a defect. The scale used includes the characters A, B, and C. A is the best clinical result.

  7. Anatomical Form

    Time frame: 5th year.

    At the control appointment, it was determined whether the restoration maintained its anatomical form. The scale used includes the characters A, B, and C. A is the best clinical result.

  8. Postoperative Sensitivity

    Time frame: 5th year.

    At the follow-up appointment, it was determined whether there was postoperative sensitivity after the restorative procedure. The scale used includes the characters A, B, and C. A is the best clinical result.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

5-year Clinical Follow-up of Bulk-fill Restorative Materials in Class II Restorations

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 1, 2024
Registry last updated
May 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.