Back to resultsPost-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
Primary Purpose
Hypersensitivity Dentin
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Immediate dentin sealing protocol
Delayed dentin sealing protocol
Sponsored by
About this trial
This is an interventional prevention trial for Hypersensitivity Dentin
Eligibility Criteria
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
Sites / Locations
- Faculty of dentistry cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Delayed dentine sealing
Immediate dentin sealing
Arm Description
Outcomes
Primary Outcome Measures
Post-operative hypersensitivity at baseline
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
Post-operative hypersensitivity one week after temporization
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
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562858
Brief Title
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
Official Title
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Dentin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delayed dentine sealing
Arm Type
Active Comparator
Arm Title
Immediate dentin sealing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Immediate dentin sealing protocol
Intervention Description
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
Intervention Type
Procedure
Intervention Name(s)
Delayed dentin sealing protocol
Intervention Description
Sealing the dentin just prior to cementation
Primary Outcome Measure Information:
Title
Post-operative hypersensitivity at baseline
Description
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
Time Frame
10 minutes
Title
Post-operative hypersensitivity one week after temporization
Description
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
Time Frame
1 week
Title
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoda Fouda, Master
Phone
01003786531
Email
Hoda.omar@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of dentistry cairo university
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoda Fouda
Phone
01003786531
Email
Hoda.omar@dentiatry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Hoda Fouda, Master
12. IPD Sharing Statement
Learn more about this trial
Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
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