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

Class II Dental Caries Clinical Trial

Official title:

Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943120
• Other study ID #: 14422019484260
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 27, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Dental Caries
• Dental Caries

Intervention

Procedure:
• "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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical performance	USPHS Criteria	day 1
Primary	clinical performance	USPHS Criteria	3 months
Primary	clinical performance	USPHS Criteria	6 months
Primary	clinical performance	USPHS Criteria	9 months
Primary	clinical performance	USPHS Criteria	12 months