Radiographic Evaluation of Adaptation of Universal Adhesives

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Class II Dental Caries

Intervention / Treatment
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* Other: Scotchbond universal adhesive plus
* Other: Single bond Universal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | Immediate |