Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities

NCT ID: NCT04943120

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2023-02-27

Brief Summary

The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.

Detailed Description

1. With limited evidence-based information about the clinical performance of resin composite in class II cavities. it is beneficial to compare the newly introduced "snow-plow' technique using a randomized clinical trial to test the null hypothesis that this new technique has the same clinical performance.

2. The comparator will be the bulk fill technique as an alternative to the conventional layering technique. This is because it has shown lower polymerization shrinkage when comparing it to the conventional composite. Bulk fill has reduced the chair time for the patient. It is done by the application of 4mm increment and cured at once.

3. Patients are selected according to the eligibility criteria discussed in the following section.

4. local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. A standard class II cavity will be prepared at the two-surface cavities.

5. The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.

6. The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.

7. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.

Conditions

Class II Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

"Snow-Plow" technique

In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.

Group Type: EXPERIMENTAL

"Snow-plow" technique

Intervention Type: PROCEDURE

In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.

Bulk Fill technique

In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.

Group Type: ACTIVE_COMPARATOR

Bulk fill technique

Intervention Type: PROCEDURE

In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.

Interventions

"Snow-plow" technique

In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.

Intervention Type: PROCEDURE

Bulk fill technique

In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• class II carious lesions in premolars and molars.
• Vital upper or lower teeth with no signs of irreversible pulpitis.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

• Deep carious defects (close to pulp, less than 1 mm distance).
• Periapical pathology or signs of pulpal pathology.
• Endodontically treated teeth
• Tooth hypersensitivity.
• Possible prosthodontic restoration of teeth.
• Heavy occlusion or occlusal contacts or history of bruxism.
• Severe periodontal affection.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Mohamed Ahmed Gomaa

Main Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

14422019484260

Identifier Type: -

Identifier Source: org_study_id