Radiographic Evaluation of Adaptation of Universal Adhesives

NCT ID: NCT05907928

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-05-31

Brief Summary

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.

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.

Conditions

Class II Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radio-opaque universal adhesive

Radio-opaque universal adhesive

Group Type: EXPERIMENTAL

Scotchbond universal adhesive plus

Intervention Type: OTHER

New generation BPA free universal adhesive

Conventional universal adhesive

Conventional universal adhesive

Group Type: ACTIVE_COMPARATOR

Single bond Universal

Intervention Type: OTHER

Radiolucent universal adhesive

Interventions

Scotchbond universal adhesive plus

New generation BPA free universal adhesive

Intervention Type: OTHER

Single bond Universal

Radiolucent universal adhesive

Intervention Type: OTHER

Other Intervention Names

Scotchbond universal adhesive

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omar Osama Shaalan

Associate Professor, Department of Conservative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Shaalan, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Department of Conservative Dentistry

Locations

Faculty of Dentistry, Cairo University

Cairo, El Manial, Egypt

Countries

Egypt

Other Identifiers

Universal adhesive plus

Identifier Type: -

Identifier Source: org_study_id