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

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ClinicalTrials.gov Identifier: NCT04790383
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Rawda Hesham Abd ElAziz, Cairo University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Caries Class II Caries,Dental Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)). Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Advanced Self-Adhesive resin composite hybrid restorations
(Surefil one (Dentsply Sirona)).
 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.
Active Comparator: Conventional resin composite restoration.
Sphere Tec, (Dentsply Sirona)
 Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
Conventional Nanohybrid resin composite


Outcome Measures
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Primary Outcome Measures :
  1. Clinical performance [ Time Frame: Change from baseline at 6, 12 months ]

    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



Eligibility Criteria
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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790383


Contacts
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Contact: Rawda Hesham Hesham A.ElAziz +201001097200 rawda.hesham@dentistry.cu.edu.eg
Contact: Dina Ezz Eldin Mohamed +20 100 800 7157 Dina.ezz@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: Cairo University         
Sponsors and Collaborators
Rawda Hesham Abd ElAziz
More Information
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Additional Information:

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Responsible Party: Rawda Hesham Abd ElAziz, lecturer at Conservative Dentistry department, Cairo University
ClinicalTrials.gov Identifier: NCT04790383    
Other Study ID Numbers: CU-2-2021
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rawda Hesham Abd ElAziz, Cairo University:
self-Adhesive resin composite hybrid restorations
Posterior resin composite
Surefil One
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Polymethyl Methacrylate
 Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs