Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05509127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2022-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: