- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562858
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
June 8, 2018 updated by: hoda omar tawfeek hussien fouda, Cairo University
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial
PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hoda Fouda, Master
- Phone Number: 01003786531
- Email: Hoda.omar@dentistry.cu.edu.eg
Study Locations
-
-
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Cairo, Egypt, 002
- Faculty of Dentistry Cairo University
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Contact:
- Hoda Fouda
- Phone Number: 01003786531
- Email: Hoda.omar@dentiatry.cu.edu.eg
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Principal Investigator:
- Hoda Fouda, Master
-
-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Extensive carious lesions indicated for indirect restorations
- Lower first molars
- Age of patients range is 18 -50 years
- Patients have not received antibiotic therapy for 1 month before sampling
- Males or Females (Both genders)
- Patients with Good oral hygiene
- Co-operative patients approving the trial
Exclusion Criteria:
- Pregnancy
- Systemic disease or severe medical
- Patients having complications as:
Periodontal problems Mobile teeth, arrest caries and non-vital teeth
- Heavy smoking patients
- Xerostomia
- Lack of compliance
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Delayed dentine sealing
|
Sealing the dentin just prior to cementation
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Experimental: Immediate dentin sealing
|
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative hypersensitivity at baseline
Time Frame: 10 minutes
|
The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group .
The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
|
10 minutes
|
Post-operative hypersensitivity one week after temporization
Time Frame: 1 week
|
The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
|
1 week
|
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
Time Frame: 1 week
|
The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration.
The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
|
1 week
|
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)
July 1, 2018
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
June 8, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 8, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-05-21
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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