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Radiographic Evaluation of Adaptation of Universal Adhesives

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ClinicalTrials.gov Identifier: NCT05907928
Recruitment Status : Not yet recruiting
First Posted : June 18, 2023
Last Update Posted : June 18, 2023
Sponsor:
Information provided by (Responsible Party):
Omar Osama Shaalan, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Class II Dental Caries Other: Scotchbond universal adhesive plus Other: Single bond Universal Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Radio-opaque universal adhesive
Radio-opaque universal adhesive
 Other: Scotchbond universal adhesive plus
New generation BPA free universal adhesive
Active Comparator: Conventional universal adhesive
Conventional universal adhesive
 Other: Single bond Universal
Radiolucent universal adhesive
Other Name: Scotchbond universal adhesive


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic Assessment of adaptation of restoration [ Time Frame: Immediate ]
    Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907928


Contacts
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Contact: Omar Shaalan, PhD 01122665661 omar.shaalan@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, El Manial, Egypt, 11553
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Omar Shaalan, PhD Lecturer, Department of Conservative Dentistry
More Information
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Responsible Party: Omar Osama Shaalan, Lecturer, Department of Conservative Dentistry, Cairo University
ClinicalTrials.gov Identifier: NCT05907928    
Other Study ID Numbers: Universal adhesive plus
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases