5-year Clinical Follow-up of Restorative Materials

NCT ID: NCT06393270

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries Class II Dental Caries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Equia Forte Fil

High-viscosity glass ionomer cement

Modified US Public Health Service (USPHS) criteria

Intervention Type DIAGNOSTIC_TEST

Dental caries classification system

Tetric Bulk Fill

Bulk-fill composite material

Modified US Public Health Service (USPHS) criteria

Intervention Type DIAGNOSTIC_TEST

Dental caries classification system

Filtek Bulk Fill

Bulk-fill composite material

Modified US Public Health Service (USPHS) criteria

Intervention Type DIAGNOSTIC_TEST

Dental caries classification system

Interventions

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Modified US Public Health Service (USPHS) criteria

Dental caries classification system

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Merve Gurses

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University, Faculty of Dentistry

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39261021 (View on PubMed)

Other Identifiers

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SelcukD

Identifier Type: -

Identifier Source: org_study_id

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