- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03696849
Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear
Patient Satisfaction and Clinical Assessment of Surface Roughness and Wear of Enamel Antagonists for Polished Versus Glazed Posterior Lithium Disilicate Glass Ceramic Crowns
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mervat Rouchdy, M.D.s
- Phone Number: 01272625020
- Email: mervatmourad82@gmail.com
Study Contact Backup
- Name: Lamia Khair Allah
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients from 18-50 years old who are able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patients have no temporomandibular disorders.
- Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
- Teeth selected shoud include:
restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.
the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.
- Willing to return for follow-up examinations and evaluation.
Exclusion criteria
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for restoration.
- Patients with temporomandibular disorders.
Study Plan
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: glazed emax Press
|
lithium disilicate glass ceramic crowns subjected to polishing only
Other Names:
|
Experimental: Polished emax Press
|
lithium disilicate glass ceramic crowns subjected to polishing only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antagonists enamel wear using profilometer
Time Frame: 1 year
|
wear of enamel antagonists opposing to emaxPress crowns that will be measured in um
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restoration surface Roughness using profilometer
Time Frame: 1 year
|
restoration roughness after different finishing methods that will me measured in um
|
1 year
|
Patient satisfaction
Time Frame: 1 year
|
Questionnaire
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-09-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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