5-year Clinical Follow-up of Restorative Materials

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06393270
• Other study ID #: SelcukD
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 15, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Class II Dental Caries
• Dental Caries

Intervention

Diagnostic Test:
• Modified US Public Health Service (USPHS) criteria
Dental caries classification system

Locations

Country	Name	City	State
Turkey	Selcuk University, Faculty of Dentistry	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.