Radiographic Evaluation of Adaptation of Universal Adhesives

NCT05907928 | Active Not Recruiting

• 1 other identifier: Universal adhesive plus
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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

  1week

Study Arms (2)

Radio-opaque universal adhesive

EXPERIMENTAL

Radio-opaque universal adhesive

Other: Scotchbond universal adhesive plus

Conventional universal adhesive

ACTIVE COMPARATOR

Conventional universal adhesive

Other: Single bond Universal

Interventions

Scotchbond universal adhesive plus OTHER

New generation BPA free universal adhesive

Radio-opaque universal adhesive

Single bond Universal OTHER

Radiolucent universal adhesive

Also known as: Scotchbond universal adhesive

Conventional universal adhesive

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

Location

Study Officials

• Omar Shaalan, PhD

  Lecturer, Department of Conservative Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Conservative Dentistry

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)