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

NCT ID: NCT06137989

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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).

Study Groups

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Fill-Up

Bulk-fill resin composite type

Group Type ACTIVE_COMPARATOR

Fill-Up Class ӀӀ restoration

Intervention Type PROCEDURE

Bulk-fill technique

QuiXfil

Bulk-fill resin composite type

Group Type ACTIVE_COMPARATOR

QuiXfil Class ӀӀ restoration

Intervention Type PROCEDURE

Bulk-fill technique

Tetric N-Ceram Bulk Fill

Bulk-fill resin composite type

Group Type ACTIVE_COMPARATOR

Tetric N-Ceram Bulk Fill Class ӀӀ restoration

Intervention Type PROCEDURE

Bulk-fill technique

Interventions

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Fill-Up Class ӀӀ restoration

Bulk-fill technique

Intervention Type PROCEDURE

QuiXfil Class ӀӀ restoration

Bulk-fill technique

Intervention Type PROCEDURE

Tetric N-Ceram Bulk Fill Class ӀӀ restoration

Bulk-fill technique

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elshirbeny Mohamed Elawsya

Lecturer, Department of Conservative Dentistry, Faculty of Dentistry, Mansoura University, Mansoura, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

Al Mansurah, Aldakhlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A01150620

Identifier Type: -

Identifier Source: org_study_id

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