Back to resultsClinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
Primary Purpose
Tooth Bleaching
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ACP oral care gel
glycrin
Sponsored by
About this trial
This is an interventional other trial for Tooth Bleaching
Eligibility Criteria
Inclusion Criteria:
- Patients must show no signs of spontaneous dental pain.
- Male or female patients between the ages of 18 to 40.
- Patients with good general and oral health.
- Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
- Patients should have central incisors determined to be shade C2 or darker
Exclusion Criteria:
- Patient with spontaneous dental pain.
- Patient with anterior restorations or non carious cervical lesion.
- Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
- Tempro-mandibular joint problems involving symptomatic pain.
- Patients taking analgesics that could alter their normal pain perception level.
- Pregnant or breast feeding women.
Sites / Locations
- Faculty of dentistry Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACP oral care geldesensitizing agent
glycrin
Arm Description
a desensitizing agent will be applied on tooth before and /or after bleaching.
glycrin will be applied on tooth before and /or after bleaching.
Outcomes
Primary Outcome Measures
Post-bleaching hypersensitivity assessed using visual analogue scale
using visual analogue scale
Secondary Outcome Measures
Tooth color assessed using value-ordered VITA® Classical Shade Guide
value-ordered VITA® Classical Shade Guide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02942082
Brief Title
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
Official Title
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent Before and /or After In-office Bleaching
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
November 29, 2018 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.
Detailed Description
A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACP oral care geldesensitizing agent
Arm Type
Experimental
Arm Description
a desensitizing agent will be applied on tooth before and /or after bleaching.
Arm Title
glycrin
Arm Type
Placebo Comparator
Arm Description
glycrin will be applied on tooth before and /or after bleaching.
Intervention Type
Other
Intervention Name(s)
ACP oral care gel
Intervention Description
a desensitizing agent will be applied on tooth before and/or after bleaching
Intervention Type
Other
Intervention Name(s)
glycrin
Intervention Description
glycrin will be applied on tooth surface before and/or after bleaching
Primary Outcome Measure Information:
Title
Post-bleaching hypersensitivity assessed using visual analogue scale
Description
using visual analogue scale
Time Frame
one month
Secondary Outcome Measure Information:
Title
Tooth color assessed using value-ordered VITA® Classical Shade Guide
Description
value-ordered VITA® Classical Shade Guide
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must show no signs of spontaneous dental pain.
Male or female patients between the ages of 18 to 40.
Patients with good general and oral health.
Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
Patients should have central incisors determined to be shade C2 or darker
Exclusion Criteria:
Patient with spontaneous dental pain.
Patient with anterior restorations or non carious cervical lesion.
Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
Tempro-mandibular joint problems involving symptomatic pain.
Patients taking analgesics that could alter their normal pain perception level.
Pregnant or breast feeding women.
Facility Information:
Facility Name
Faculty of dentistry Cairo university
City
Cairo
ZIP/Postal Code
11651
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
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