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NCT Number: NCT05907928

Radiographic Evaluation of Adaptation of Universal Adhesives

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scotchbond universal adhesive plus

Other

New generation BPA free universal adhesive

Single bond Universal

Other

Radiolucent universal adhesive

Other names: Scotchbond universal adhesive

Primary outcomes

  1. Radiographic Assessment of adaptation of restoration

    Time frame: 1week

    Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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