Clinical trial NCT04943120: 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
Overall status: COMPLETED
Phase: NA
Conditions: Class II Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical performance
timeFrame: day 1
measure: clinical performance
timeFrame: 3 months
measure: clinical performance
timeFrame: 6 months
measure: clinical performance
timeFrame: 9 months
measure: clinical performance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
Study officials:
References: