Radiographic Evaluation of Adaptation of Universal Adhesives

Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial

Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.

Study Overview

• Status: Active, not recruiting
• Conditions: Class II Dental Caries
• Intervention / Treatment: Other: Scotchbond universal adhesive plus; Other: Single bond Universal

Detailed Description

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 bisphenol 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, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11553
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4)
• 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 tempromandibular joint disorders.
• 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radio-opaque universal adhesive	Other: Scotchbond universal adhesive plus; New generation BPA free universal adhesive
Active Comparator: Conventional universal adhesive	Other: Single bond Universal; Radiolucent universal adhesive; Other Names: Scotchbond universal adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessment of adaptation of restoration	Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration	1week

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Omar Shaalan, PhD, Lecturer, Department of Conservative Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: Universal adhesive plus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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