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Radiographic Evaluation of Adaptation of Universal Adhesives

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05907928
Enrollment
30
Registered
2023-06-18
Start date
2025-04-01
Completion date
2025-05-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Dental Caries

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.

Interventions

OTHERScotchbond universal adhesive plus

New generation BPA free universal adhesive

Radiolucent universal adhesive

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic Assessment of adaptation of restoration1weekModified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026