- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340869
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents
April 9, 2020 updated by: ebtsam kassab, Al-Azhar University
The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity
Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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: Ebtsam Kassab
- Phone Number: +201005889938
- Email: dentiebtsamkassab@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 11111
- Recruiting
- Al-Azhar University , Faculty of Dental medicine for Girls
-
Contact:
- Ebtsam Kassab
- Phone Number: +201005889938
- Email: dentiebtsamkassab@gmail.com
-
-
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
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.(
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Theobromine
Natural extract from Cocoa
|
Natural extract from Cocoa
|
Active Comparator: Remin Pro
Fluoride , Hydroxyapatite , and Xylitol
|
Remin Pro
|
Experimental: Combination
Remin Pro and Theobromine
|
Natural extract from Cocoa
Remin Pro
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale pain score
Time Frame: 1 month
|
0 = no pain to 10=severe exagerated pain
|
1 month
|
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 (Actual)
August 1, 2019
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
March 2, 2020
First Submitted That Met QC Criteria
April 9, 2020
First Posted (Actual)
April 10, 2020
Study Record Updates
Last Update Posted (Actual)
April 10, 2020
Last Update Submitted That Met QC Criteria
April 9, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC18-145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
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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