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

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04943120
Collaborator
(none)
32
1
2
12.7
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: "Snow-plow" technique
  • Procedure: Bulk fill technique
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:11:1
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial
Actual Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: "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.

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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. clinical performance [day 1]

    USPHS Criteria

  2. clinical performance [3 months]

    USPHS Criteria

  3. clinical performance [6 months]

    USPHS Criteria

  4. clinical performance [9 months]

    USPHS Criteria

  5. clinical performance [12 months]

    USPHS Criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry Cairo Egypt 002

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mariam Mohamed Ahmed Gomaa, Main Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04943120
Other Study ID Numbers:
  • 14422019484260
First Posted:
Jun 29, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022