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

Dental Caries Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137989
• Other study ID #: A01150620
• Status: Completed
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

Intervention

Procedure:
• Fill-Up Class ?? restoration
Bulk-fill technique
• QuiXfil Class ?? restoration
Bulk-fill technique
• Tetric N-Ceram Bulk Fill Class ?? restoration
Bulk-fill technique

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Mansoura University, Mansoura, Egypt.	Mansoura	Aldakhlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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