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Completed

NCT Number: NCT06137989

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

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.

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Key information

Conditions

Dental Caries Class II

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Al Mansurah, Aldakhlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fill-Up Class ӀӀ restoration

Procedure

Bulk-fill technique

QuiXfil Class ӀӀ restoration

Procedure

Bulk-fill technique

Tetric N-Ceram Bulk Fill Class ӀӀ restoration

Procedure

Bulk-fill technique

Primary outcomes

  1. Esthetic properties (FDI criteria)

    Time frame: From baseline to 2-year follow-up

    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).

  2. Functional properties (FDI criteria)

    Time frame: From baseline to 2-year follow-up

    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).

  3. Biological properties (FDI criteria)

    Time frame: From baseline to 2-year follow-up

    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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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