Clinical Performance
Conditions
Keywords
Performance, Carious, Cervical, Universal adhesive, USPHS criteria
Brief summary
Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.
Detailed description
The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include: * Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch. * Usage with direct and indirect indications. * Bonding to all dental surfaces without the need for separate primers or silanes * Virtually no post-operative sensitivity. The newly modified adhesive with its careful formulation offers: * Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment. * Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure. * Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics. * Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle. * A BPA derivative-free formulation to alleviate concerns about BPA in dental materials * A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications. As with any new material or technique, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.
Interventions
DRUGModified universal adhesive
Application of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds.
DRUGConventional universal adhesive
Application of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Small to moderate carious cervical lesions. (ICDAS scores 3,4) * Upper premolar teeth. * Good oral hygiene (mild to moderate plaque accumulation) * Vital teeth with no signs of irreversible pulpitis. * Presence of favorable occlusion and normal contact with adjacent teeth.
Exclusion criteria
* Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates. * Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia. * Evidence of parafunctional habits and TMJ disorders. * Class V lesions in molars. * Non-carious cervical lesions. * Deep carious defects (close to pulp, less than 1 mm distance). * Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. * Endodontically treated teeth. * Tooth hypersensitivity. * Possible prosthodontic restoration of teeth. * Heavy occlusion and occlusal contacts or history of bruxism. * Severe periodontal affection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marginal adaptation | Baseline, 6 months, 12 months, 18 months and 24 months. | using Modified USPHS criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal discoloration | Baseline, 6 months, 12 months, 18 months and 24 months. | using Modified USPHS criteria |
| Post-operative sensitivity | Baseline, 6 months, 12 months, 18 months and 24 months. | using Modified USPHS criteria |
| Retention | Baseline, 6 months, 12 months, 18 months and 24 months. | using Modified USPHS criteria |
| Secondary caries | Baseline, 6 months, 12 months, 18 months and 24 months. | using Modified USPHS criteria |
Countries
Egypt
Outcome results
None listed