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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Performance
• Intervention / Treatment: Drug: Modified universal adhesive; Drug: Conventional universal adhesive

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carious cervical lesions treated with modified universal adhesive; Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite.	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.; Other Names: 3M ESPE™ Scotchbond Universal Plus Adhesive
Active Comparator: Carious cervical lesions treated with conventional universal adhesive; Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite.	Drug: 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.; Other Names: 3M ESPE™ Single Bond Universal Adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Marginal adaptation	using Modified USPHS criteria	Baseline, 6 months, 12 months, 18 months and 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal discoloration	using Modified USPHS criteria	Baseline, 6 months, 12 months, 18 months and 24 months.
Post-operative sensitivity	using Modified USPHS criteria	Baseline, 6 months, 12 months, 18 months and 24 months.
Retention	using Modified USPHS criteria	Baseline, 6 months, 12 months, 18 months and 24 months.
Secondary caries	using Modified USPHS criteria	Baseline, 6 months, 12 months, 18 months and 24 months.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 15, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cervical; Performance; Carious; Universal adhesive; USPHS criteria
• Other Study ID Numbers: Modified Universal Adhesive

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No