5-year Clinical Follow-up of Restorative Materials

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Class II Dental Caries
• Intervention / Treatment: Diagnostic test: Modified US Public Health Service (USPHS) criteria

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selcuk University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Seventy-nine patients (50 females, 29 males) between the ages of 18 and 53, and 192 restorations meeting the criteria were included in the study.

Description

Inclusion Criteria:

• Patients who were;

  1. older than 18 years old
  2. had good general health and oral hygiene
  3. had interface restorations of similar size in their premolars and molars
  4. were able to attend control appointments were included The teeth were determined as follows;
  1. in contact with the opposing tooth
  2. exposed to normal occlusal forces on the dentition
  3. restoration width not exceeding 1⁄2 of the intercuspal distance
  4. normal response to vitality tests without periodontal pathology

Exclusion Criteria:

• Patients with;

  1. poor oral hygiene
  2. those with active periodontal disease
  3. those with severe bruxism
  4. pregnant and lactating women
  5. endodontically treated teeth were excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Equia Forte Fil; High-viscosity glass ionomer cement	Diagnostic test: Modified US Public Health Service (USPHS) criteria; Dental caries classification system
Tetric Bulk Fill; Bulk-fill composite material	Diagnostic test: Modified US Public Health Service (USPHS) criteria; Dental caries classification system
Filtek Bulk Fill; Bulk-fill composite material	Diagnostic test: Modified US Public Health Service (USPHS) criteria; Dental caries classification system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	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.	5th year.
Color Match	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.	5th year.
Marginal Adaptation	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.	5th year.
Marginal Discoloration	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.	5th year.
Secondary Caries	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.	5th year.
Surface Texture	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.	5th year.
Anatomical Form	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.	5th year.
Postoperative Sensitivity	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.	5th year.

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: SelcukD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No