- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05465850
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth
July 16, 2022 updated by: Dina Khaled Mokhtar Mohamed, Cairo University
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Class V carious lesions in anterior teeth
- Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
Exclusion Criteria:
- Deep carious defects ( Close to pulp, less than 1 mm distance)
- Periapical pathology or signs of pulpal pathology
- Endodontically treated teeth
- Tooth hypersensitivity
- Possible prosthodontic restoration of teeth
- Heavy occlusion and occlusal contacts or history of bruxism
- Severe periodontal affection
- Lesions in premolars and molars
- Posterior teeth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Filtek Z350XT
|
It assess the restorations with visual inspection using a mirror and explorer.
It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
|
Experimental: Essentia universal shade, GC composite
|
It assess the restorations with visual inspection using a mirror and explorer.
It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
|
Experimental: Omnichroma composite
|
It assess the restorations with visual inspection using a mirror and explorer.
It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical performance (USPHS criteria)
Time Frame: baseline: 1 week
|
USPHS criteria
|
baseline: 1 week
|
Clinical performance (USPHS criteria)
Time Frame: 6 months
|
USPHS criteria
|
6 months
|
Clinical performance (USPHS criteria)
Time Frame: 12 months
|
USPHS criteria
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
July 16, 2022
First Posted (Actual)
July 20, 2022
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 16, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14422019428237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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