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

NCT06137989 | Completed

• 1 other identifier: A01150620
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries Class II

Keywords

Bulk-fill resin composite; Dual-cure; Light-cure; Class ӀӀ restorations; Clinical performance; Randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Fill-Up

ACTIVE COMPARATOR

Bulk-fill resin composite type

Procedure: Fill-Up Class ӀӀ restoration

QuiXfil

ACTIVE COMPARATOR

Bulk-fill resin composite type

Procedure: QuiXfil Class ӀӀ restoration

Tetric N-Ceram Bulk Fill

ACTIVE COMPARATOR

Bulk-fill resin composite type

Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration

Interventions

Fill-Up Class ӀӀ restoration PROCEDURE

Bulk-fill technique

Fill-Up

QuiXfil Class ӀӀ restoration PROCEDURE

Bulk-fill technique

QuiXfil

Tetric N-Ceram Bulk Fill Class ӀӀ restoration PROCEDURE

Bulk-fill technique

Tetric N-Ceram Bulk Fill

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Al Mansurah, Aldakhlia, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Except the investigator, the participants and the two clinical examiners were blinded to the type of bulk-fill resin composite applied in each tooth (a double-blinded clinical trial).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Conservative Dentistry, Faculty of Dentistry, Mansoura University, Mansoura, Egypt

Model Details: Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: August 4, 2020
• Primary Completion: August 20, 2022
• Study Completion: August 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

EG (1)