Back to resultsTreatment of Dentin Hypersensitivity Using Different Desensitizing Agents
Primary Purpose
Dentin Sensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Theobromine
Remin Pro
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Patients that aged 18-50 years.
- Patients in good general health.
- Patients that have accessible teeth demonstrating signs of sensitivity.
Exclusion Criteria:
• Any chronic debilitating disease that could influence study outcomes.
- Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
- Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
- Desensitising treatment or tooth bleaching within 8 weeks of screening.
- Daily use of medications that might influence the perception of pain.(
Sites / Locations
- Al-Azhar University , Faculty of Dental medicine for GirlsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Theobromine
Remin Pro
Combination
Arm Description
Natural extract from Cocoa
Fluoride , Hydroxyapatite , and Xylitol
Remin Pro and Theobromine
Outcomes
Primary Outcome Measures
Visual analogue scale pain score
0 = no pain to 10=severe exagerated pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340869
Brief Title
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents
Official Title
The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Theobromine
Arm Type
Experimental
Arm Description
Natural extract from Cocoa
Arm Title
Remin Pro
Arm Type
Active Comparator
Arm Description
Fluoride , Hydroxyapatite , and Xylitol
Arm Title
Combination
Arm Type
Experimental
Arm Description
Remin Pro and Theobromine
Intervention Type
Other
Intervention Name(s)
Theobromine
Intervention Description
Natural extract from Cocoa
Intervention Type
Other
Intervention Name(s)
Remin Pro
Intervention Description
Remin Pro
Primary Outcome Measure Information:
Title
Visual analogue scale pain score
Description
0 = no pain to 10=severe exagerated pain
Time Frame
1 month
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:
Patients that aged 18-50 years.
Patients in good general health.
Patients that have accessible teeth demonstrating signs of sensitivity.
Exclusion Criteria:
• Any chronic debilitating disease that could influence study outcomes.
Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
Desensitising treatment or tooth bleaching within 8 weeks of screening.
Daily use of medications that might influence the perception of pain.(
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebtsam Kassab
Phone
+201005889938
Email
dentiebtsamkassab@gmail.com
Facility Information:
Facility Name
Al-Azhar University , Faculty of Dental medicine for Girls
City
Cairo
ZIP/Postal Code
11111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebtsam Kassab
Phone
+201005889938
Email
dentiebtsamkassab@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents
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