Clinical efficacy of universal adhesive for the restoration of non carious cervical lesion:A Randomized clinical trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Marginal staining
Study Overview
Brief Summary
Purpose: The objective of this double-blind randomized clinical trial was to evaluate the one year clinical performance of a new universal adhesive in noncarious cervical lesions (NCCLs) using the US Public Health Service (USPHS) evaluation criteria
Methods and Materials: A total of 100 restorations will be randomly placed in patients according to the following groups: SE-et = selective enamel etching; and SET = self-etch. The composite resin will be placed and the restorations will be evaluated after one week (baseline) and at six months using and one year USPHS criteria to check the postoperative sensitivity fracture and marginal staining in non carious cervical lesions.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patient requiring restoratons in the cervical region in a minimum of two sides and one tooth in each side
- •Cervical lesions with a depth of 1-3mm and width of 2-4mm
- •Patients willing to participate and sign the informed consent form
- •Subjects who have natural dentition directly opposing the test restoration.
- •â€¢Patients having good oral hygiene.
Exclusion Criteria
- •1.ndividual with a chronic systemic disease with or without oral manifestations.
- •Individual with periodontal problems.
- •Subjects with known allergy to any materials used
- •Individual with bruxism and other parafunctional habits.
Outcomes
Primary Outcomes
Marginal staining
Time Frame: 7 days | 6months | 1 year
Sensitivity
Time Frame: 7 days | 6months | 1 year
Fracture
Time Frame: 7 days | 6months | 1 year
Secondary Outcomes
- Marginal staining(Sensitivity)