Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-27 @ 12:04 PM
Study NCT ID:
NCT06562868
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2024-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials
Sponsor:
TC Erciyes University
Organization:
Study Overview
Official Title:
Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the clinical success of different filling materials used in the treatment of dental caries. Systemically healthy individuals with good oral hygiene and interproximal caries in their posterior teeth participated in the study. Participants underwent initial radiographic and intraoral examinations. Three different filling materials were applied to the participants' teeth. The restorations were evaluated at baseline, 1 year, and 2 years.
Detailed Description:
The aim of this study was to evaluate the clinical performance of Class II carious defects restored with traditional posterior composite, bulk-fill composite, and high-fill flowable composite resin according to the World Dental Federation (FDI) criteria at 12-month and 24-month intervals. In this study, 110 patients underwent initial radiographic and intraoral examinations. Radiographically, 259 teeth with interproximal caries at D1 and D2 levels were identified. All restorations in the study were performed by the same dentist. Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions..The first group received bulk-fill composite resin (Filtek One Bulk Fill Restorative), the second group received traditional posterior composite (Clearfil Majesty Posterior ), and the third group received high-filler flowable composite resin. The same universal dental adhesive system was used for all groups. All restorations were evaluated by two experienced dentists according to the FDI evaluation criteria at baseline,1 year and 2 years. In cases where discrepancies were observed between the two examiners, the assessment was based on a consensus decision made by both dentists. Restorations were evaluated and scored separately for each criterion on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: