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NCT04790383 Clinical Trial

Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.

Caries,Dental Clinical Trial

Official title:
Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04790383
Other study ID # CU-2-2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date March 2022

Study information
Verified date March 2021
Source Cairo University
Contact Rawda Hesham Hesham A.ElAziz
Phone +201001097200
Email rawda.hesham@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.

Recruitment information / eligibility
Status Recruiting
Enrollment 63
Est. completion date March 2022
Est. primary completion date February 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 55 Years
Eligibility Inclusion Criteria: - Patients with carious proximal cavities in molars - Good oral hygiene. - Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: - Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. - Severe periodontal problems.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).
Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.
• Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
Conventional Nanohybrid resin composite

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Rawda Hesham Abd ElAziz

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performance Post operative Hypersensitivity, Secondary caries, Gross fracture, Cavo-surface marginal discoloration, Proximal contact.
All these outcomes are measured by a score Alpha is excellent, Bravo is acceptable, Charlie is not accepted		 Change from baseline at 6, 12 months
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