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

• Sponsor: Rawda Hesham Abd ElAziz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04790383
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

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

Primary Outcome Measures

1. Clinical performance [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

Criteria

• Ages Eligible for Study: 17 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Rawda Hesham Abd ElAziz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• 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: Mar 10, 2021
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, lecturer at Conservative Dentistry department, Cairo University: self-Adhesive resin composite hybrid restorations; Posterior resin composite; Surefil One
• Additional relevant MeSH terms: Dental Caries; Polymethyl Methacrylate

Study Results

No Results Posted as of Mar 10, 2021