Clinical trial NCT05509127: Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive
Official title: Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Clinical Performance
Keywords: Performance
Carious
Cervical
Universal adhesive
USPHS criteria
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Marginal adaptation
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months.
Secondary outcomes:
measure: Marginal discoloration
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months.
measure: Post-operative sensitivity
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months.
measure: Retention
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months.
measure: Secondary caries
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
References: