Status:
COMPLETED
Efficacy of CPP-ACP on Bleaching Related Sensitivity
Lead Sponsor:
University of New England
Collaborating Sponsors:
University of Iowa
Conditions:
Teeth Sensitivity
Tooth Discoloration
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching. Methods: 45 subjects ...
Detailed Description
Study Design This was a randomized, controlled, split-mouth cross-over design clinical trial. Subjects were randomized into two groups depending on the control and intervention arches: * Group 1: Th...
Eligibility Criteria
Inclusion
- Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
- Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
- Subjects who were available for a potential recall period of one year.
- Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
Exclusion
- Subjects who had any known allergies to any materials used in this protocol.
- Patients with milk protein allergies since one of the materials used is derived from milk protein.
- Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
- Subjects involved in other clinical trials utilizing a similar protocol.
- Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
- The subjects who have used any desensitizing agents including toothpaste in the past six months.
- Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
- Subjects who had any periodontal surgery or scaling performed in the past six months.
Key Trial Info
Start Date :
July 16 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04112706
Start Date
July 16 2006
End Date
March 16 2007
Last Update
October 2 2019
Active Locations (1)
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1
University of New England
Portland, Maine, United States, 04101