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Active, not recruiting Phase 1

Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive

NCT05509127 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1
Started
2023-01-01
Last updated
2024-10-16

Condition(s) studied

Clinical Performance

Investigational drug(s) / intervention(s)

Modified universal adhesiveConventional universal adhesive

Modified universal adhesive: Application of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds.

Conventional universal adhesive: Application of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds.

Study summary

Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.

Eligibility

Sex
ALL
Min age
20 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Small to moderate carious cervical lesions. (ICDAS scores 3,4) * Upper premolar teeth. * 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 TMJ disorders. * Class V lesions in molars. * Non-carious cervical lesions. * 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 outcome measure(s)

  • Change in Marginal adaptation — Baseline, 6 months, 12 months, 18 months and 24 months.
    using Modified USPHS criteria

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry - Cairo University Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05509127 on ClinicalTrials.gov ↗ ← All trials in Egypt