Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities
Primary Purpose
Class II Dental Caries
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
"Snow-plow" technique
Bulk fill technique
Sponsored by
About this trial
This is an interventional treatment trial for Class II Dental Caries
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.
Sites / Locations
- Faculty of dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"Snow-Plow" technique
Bulk Fill technique
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
clinical performance
USPHS Criteria
clinical performance
USPHS Criteria
clinical performance
USPHS Criteria
clinical performance
USPHS Criteria
clinical performance
USPHS Criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04943120
Brief Title
Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities
Official Title
Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
March 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
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.
Patients are selected according to the eligibility criteria discussed in the following section.
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.
The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.
The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.
The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Snow-Plow" technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Bulk Fill technique
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
"Snow-plow" technique
Intervention Description
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
Intervention Name(s)
Bulk fill technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical performance
Description
USPHS Criteria
Time Frame
day 1
Title
clinical performance
Description
USPHS Criteria
Time Frame
3 months
Title
clinical performance
Description
USPHS Criteria
Time Frame
6 months
Title
clinical performance
Description
USPHS Criteria
Time Frame
9 months
Title
clinical performance
Description
USPHS Criteria
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of dentistry
City
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities
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