Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites

Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial

This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.

The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.

Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.

Study Overview

• Status: Completed
• Conditions: Dental Caries Class II
• Intervention / Treatment: Procedure: Fill-Up Class ӀӀ restoration; Procedure: QuiXfil Class ӀӀ restoration; Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aldakhlia
    • Mansoura, Aldakhlia, Egypt, 35516
      • Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
• all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.

Exclusion Criteria:

General exclusion criteria:

• heavy bruxism.
• poor oral hygiene.
• chronic or severe periodontitis.
• a history of allergies to any of the materials utilized in this study.
• pregnant or nursing females.

Specific exclusion criteria:

• fractured or visibly cracked teeth.
• rampant caries.
• faulty restoration opposite or adjacent to the tooth to be restored.
• atypical extrinsic staining.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fill-Up; Bulk-fill resin composite type	Procedure: Fill-Up Class ӀӀ restoration; Bulk-fill technique
Active Comparator: QuiXfil; Bulk-fill resin composite type	Procedure: QuiXfil Class ӀӀ restoration; Bulk-fill technique
Active Comparator: Tetric N-Ceram Bulk Fill; Bulk-fill resin composite type	Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration; Bulk-fill technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esthetic properties (FDI criteria)	Including five parameters (surface luster, margin staining, surface staining, color match & translucency, and esthetic anatomical form). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).	From baseline to 2-year follow-up
Functional properties (FDI criteria)	Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material & retention). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).	From baseline to 2-year follow-up
Biological properties (FDI criteria)	Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).	From baseline to 2-year follow-up

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): August 20, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Clinical performance; Bulk-fill resin composite; Dual-cure; Light-cure; Class ӀӀ restorations
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: A01150620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No