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Active Not RecruitingNCT05509127

Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive

Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGModified universal adhesiveApplication 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 adhesiveApplication 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.

Timeline

Start date
2023-01-01
Primary completion
2024-08-15
Completion
2025-01-01
First posted
2022-08-19
Last updated
2024-10-16

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05509127. Inclusion in this directory is not an endorsement.