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5-year Clinical Follow-up of Restorative Materials

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06393270
Enrollment
192
Registered
2024-05-01
Start date
2017-11-01
Completion date
2022-12-15
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Dental Caries, Dental Caries

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.

Interventions

DIAGNOSTIC_TESTModified US Public Health Service (USPHS) criteria

Dental caries classification system

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Retention5th 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.
Color Match5th 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.
Marginal Adaptation5th 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.
Marginal Discoloration5th 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.
Secondary Caries5th 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.
Surface Texture5th 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.
Anatomical Form5th 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.
Postoperative Sensitivity5th 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026