5-year Clinical Follow-up of Restorative Materials

NCT06393270 | Completed

• 1 other identifier: SelcukD
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries; Class II Dental Caries

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (3)

Equia Forte Fil

High-viscosity glass ionomer cement

Diagnostic Test: Modified US Public Health Service (USPHS) criteria

Tetric Bulk Fill

Bulk-fill composite material

Diagnostic Test: Modified US Public Health Service (USPHS) criteria

Filtek Bulk Fill

Bulk-fill composite material

Diagnostic Test: Modified US Public Health Service (USPHS) criteria

Interventions

Modified US Public Health Service (USPHS) criteria DIAGNOSTIC_TEST

Dental caries classification system

Equia Forte Fil; Filtek Bulk Fill; Tetric Bulk Fill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;
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• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

Related Publications (1)

• Gurses M, Inan B, Cobanoglu N, Turkmen ATK. Five-year clinical follow-up of bulk-fill restorative materials in class II restorations. Dent Mater J. 2024 Sep 28;43(5):746-754. doi: 10.4012/dmj.2024-132. Epub 2024 Sep 10.

  PMID: 39261021 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: November 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2022
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

TU (1)