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Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT

Primary Purpose

Decay, Dental, Caries Class II

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Short fiber reinforced flowable resin composite restorations
Conventional resin composite restoration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decay, Dental focused on measuring short fiber reinforced flowable resin composite, Clinical performance, Ever X flow, Randomized clinical study

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with large proximal carious cavities in molars.
  • Pulp asymptomatic vital carious upper or lower molars.
  • Good oral hygiene.

Exclusion Criteria:

  • Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
  • Severe medical complications.
  • Allergic history concerning methacrylates
  • Evidence of parafunctional habits.

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short fiber reinforced flowable resin composite restorations

Conventional resin composite restoration.

Arm Description

(everX Flow, GC Europe) + (Gaenial posterior, GC Europe

(Gaenial posterior, GC Europe)

Outcomes

Primary Outcome Measures

Clinical performance (Alpha is the best score, bravo, charlie the worst score)
Modified USPHS criteria; . Post operative Hypersensitivity Secondary caries Gross fracture Color match Cavo-surface marginal discoloration Marginal integrity Proximal contact

Secondary Outcome Measures

Full Information

First Posted
January 19, 2021
Last Updated
January 22, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04720638
Brief Title
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT
Official Title
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decay, Dental, Caries Class II
Keywords
short fiber reinforced flowable resin composite, Clinical performance, Ever X flow, Randomized clinical study

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Short fiber reinforced flowable resin composite restorations
Arm Type
Experimental
Arm Description
(everX Flow, GC Europe) + (Gaenial posterior, GC Europe
Arm Title
Conventional resin composite restoration.
Arm Type
Active Comparator
Arm Description
(Gaenial posterior, GC Europe)
Intervention Type
Other
Intervention Name(s)
Short fiber reinforced flowable resin composite restorations
Other Intervention Name(s)
Ever X Flow
Intervention Description
reinforced flowable resin composite
Intervention Type
Other
Intervention Name(s)
Conventional resin composite restoration
Other Intervention Name(s)
Gaenial posterior, GC Europe
Intervention Description
Microhybrid resin composite
Primary Outcome Measure Information:
Title
Clinical performance (Alpha is the best score, bravo, charlie the worst score)
Description
Modified USPHS criteria; . Post operative Hypersensitivity Secondary caries Gross fracture Color match Cavo-surface marginal discoloration Marginal integrity Proximal contact
Time Frame
Change from baseline at 6, 12 ,18, 24 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 large proximal carious cavities in molars. Pulp asymptomatic vital carious upper or lower molars. Good oral hygiene. Exclusion Criteria: Presence of signs and symptoms of irreversible pulpitis or pulp necrosis Severe medical complications. Allergic history concerning methacrylates Evidence of parafunctional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rawda Hesham A ElAziz
Phone
01001097200
Email
rawda.hesham@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sherifa Ahmed
Email
Sherifa.Ahmed@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rawda Hesham
Organizational Affiliation
Lecturer at faculty of Dentistry- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11331
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rawda Hesham Abd ElAziz
Phone
01001097200
Email
rawda.hesham@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT

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