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

Primary Purpose

Caries Class II, Caries,Dental

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).
Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
Sponsored by
Rawda Hesham Abd ElAziz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Class II focused on measuring self-Adhesive resin composite hybrid restorations, Posterior resin composite, Surefil One

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Advanced Self-Adhesive resin composite hybrid restorations

Conventional resin composite restoration.

Arm Description

(Surefil one (Dentsply Sirona)).

Sphere Tec, (Dentsply Sirona)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 4, 2021
Last Updated
March 5, 2021
Sponsor
Rawda Hesham Abd ElAziz
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1. Study Identification

Unique Protocol Identification Number
NCT04790383
Brief Title
Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.
Official Title
Clinical Performance of Advanced Self-Adhesive Resin Composite Hybrid Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (1y Randomized Clinical Trial).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rawda Hesham Abd ElAziz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Class II, Caries,Dental
Keywords
self-Adhesive resin composite hybrid restorations, Posterior resin composite, Surefil One

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Self-Adhesive resin composite hybrid restorations
Arm Type
Experimental
Arm Description
(Surefil one (Dentsply Sirona)).
Arm Title
Conventional resin composite restoration.
Arm Type
Active Comparator
Arm Description
Sphere Tec, (Dentsply Sirona)
Intervention Type
Other
Intervention Name(s)
Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).
Intervention Description
Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.
Intervention Type
Other
Intervention Name(s)
Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona
Intervention Description
Conventional Nanohybrid resin composite
Primary Outcome Measure Information:
Title
Clinical performance
Description
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
Time Frame
Change from baseline at 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rawda Hesham Hesham A.ElAziz
Phone
+201001097200
Email
rawda.hesham@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Ezz Eldin Mohamed
Phone
+20 100 800 7157
Email
Dina.ezz@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo University

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.dentsplysirona.com/en/explore/restorative/surefil-one.html
Description
Related Info

Learn more about this trial

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

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