Radiographic Evaluation of Adaptation of Universal Adhesives

Not Applicable

Active, not recruiting

• Conditions: Class II Dental Caries
• Interventions: Other: Scotchbond universal adhesive plus; Other: Single bond Universal

• Registration Number: NCT05907928
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-18
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Last Update Submitted: 2025-05-10
• Last Update Posted: 2025-05-14
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radio-opaque universal adhesive	Scotchbond universal adhesive plus	Radio-opaque universal adhesive
Conventional universal adhesive	Single bond Universal	Conventional universal adhesive

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, El Manial, Egypt