- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04855279
Prevention of Bleaching Induced Sensitivity
Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Medipol Mega University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Must have all their upper and lower anterior teeth
Must have good oral hygiene
EXCLUSION CRITERIA:
Pregnancy or breastfeeding
Systemic disease
Taking NSAIDs or other drug treatment.
Periodontal disease
Enamel hypoplasia
Teeth stained by tetracycline or fluorosis
Dental malposition or orthodontic treatment with fixed appliances
Canine teeth lighter than A1
Restoration on anterior teeth
Cervical lesions
Symptoms of dental pain
Previous tooth whitening experience.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
Topically applied
|
Active Comparator: Topical neutral sodium fluoride
|
Topically applied
|
Active Comparator: ACP-CCP gel
|
Topically applied
|
Active Comparator: nano-hydroxyapatite solution
|
Topically applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of reducing hypersensitivity after bleaching
Time Frame: 1 week
|
VAS scale (Visual Analog Scale) was measured before and after bleaching
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benin Dikmen, Dr., Medipol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KN453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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