Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive

Clinical Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05509127
• Other study ID #: Modified Universal Adhesive
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Performance

Intervention

Drug:
• Modified 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.
• Conventional 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Marginal adaptation	using Modified USPHS criteria	Baseline, 6 months, 12 months and 18 months.
Secondary	Marginal discoloration	using Modified USPHS criteria	Baseline, 6 months, 12 months and 18 months.
Secondary	Post-operative sensitivity	using Modified USPHS criteria	Baseline, 6 months, 12 months and 18 months.
Secondary	Retention	using Modified USPHS criteria	Baseline, 6 months, 12 months and 18 months.
Secondary	Secondary caries	using Modified USPHS criteria	Baseline, 6 months, 12 months and 18 months.