Radiographic Evaluation of Adaptation of Universal Adhesives

Class II Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05907928
• Other study ID #: Universal adhesive plus
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: Omar Shaalan, PhD
• Phone: 01122665661
• Email: omar.shaalan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Dental Caries
• Dental Caries

Intervention

Other:
• Scotchbond universal adhesive plus
New generation BPA free universal adhesive
• Single bond Universal
Radiolucent universal adhesive

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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