Back to resultsClinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Primary Purpose
Carious Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
Sponsored by
About this trial
This is an interventional treatment trial for Carious Teeth
Eligibility Criteria
Inclusion Criteria:
• They should have an acceptable oral hygiene level.
- Presence of at least two occlusal carious lesions to be restored with two different types of composite.
- The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
- Age range between 25 and 45years.
Exclusion Criteria:
• Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion
- Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
- Alcoholic and smoker patients.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for recall appointment
Sites / Locations
- Ruba Salah Anwar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Universal single shade resin composite restorative material
Nano-hybrid multi-shade resin composite restorative material
Arm Description
Dental restorative material
Dental restorative material
Outcomes
Primary Outcome Measures
USPSH criteria
Alpha and Beta are clinically successful, Charlie and Delta are clinically failure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05500547
Brief Title
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Official Title
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia 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
This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.
Detailed Description
One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Universal single shade resin composite restorative material
Arm Type
Experimental
Arm Description
Dental restorative material
Arm Title
Nano-hybrid multi-shade resin composite restorative material
Arm Type
Active Comparator
Arm Description
Dental restorative material
Intervention Type
Other
Intervention Name(s)
US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations
Other Intervention Name(s)
assessment of Universal single shade resin composite and Nano-hybrid multi-shade resin composite restorative material using the US Public Health Service "USPSH" criteria
Intervention Description
US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.
Primary Outcome Measure Information:
Title
USPSH criteria
Description
Alpha and Beta are clinically successful, Charlie and Delta are clinically failure
Time Frame
For 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• They should have an acceptable oral hygiene level.
Presence of at least two occlusal carious lesions to be restored with two different types of composite.
The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
Age range between 25 and 45years.
Exclusion Criteria:
• Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion
Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
Alcoholic and smoker patients.
Patients had participated in a clinical trial within 6 months before commencement of this trial.
Patients unable to return for recall appointment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona I Riad, Prof
Organizational Affiliation
Minia University
Official's Role
Study Director
Facility Information:
Facility Name
Ruba Salah Anwar
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
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