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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06137989
Enrollment
40
Registered
2023-11-18
Start date
2020-08-04
Completion date
2022-08-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Class II

Keywords

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

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.

Interventions

PROCEDUREFill-Up Class ӀӀ restoration

Bulk-fill technique

PROCEDUREQuiXfil Class ӀӀ restoration

Bulk-fill technique

PROCEDURETetric N-Ceram Bulk Fill Class ӀӀ restoration

Bulk-fill technique

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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).

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Esthetic properties (FDI criteria)From baseline to 2-year follow-upIncluding 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).
Functional properties (FDI criteria)From baseline to 2-year follow-upIncluding 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).
Biological properties (FDI criteria)From baseline to 2-year follow-upIncluding 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026