Clinical trial NCT05907928: Radiographic Evaluation of Adaptation of Universal Adhesives
Official title: Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class II Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Radiographic Assessment of adaptation of restoration
timeFrame: 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: El Manial
Study officials:
affiliation: Lecturer, Department of Conservative Dentistry
name: Omar Shaalan, PhD
role: PRINCIPAL_INVESTIGATOR
References: