Status:
COMPLETED
This is a Study to Determine the Clinical Evaluation of Enamel Microhardness Using At-Home and In-Office Tooth Whitening Agents
Lead Sponsor:
Ultradent Products, Inc.
Collaborating Sponsors:
Universidad Intercontinental
Indiana University
Conditions:
Dental Atraumatic Restorative Treatment
Eligibility:
All Genders
12-35 years
Phase:
NA
Brief Summary
The examiner will review the medical history taken by your orthodontist that determined your eligibility to participate in this study on the first appointment. If the examiner determines that the posi...
Detailed Description
14- PROJECT METHODOLOGY: Methods and materials This study consists of 40 patients requiring the extraction of four permanent first or second premolars for orthodontic reasons. Patients will be recruit...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have the four premolars in different quadrants that their orthodontist recommends be extracted.
- The premolars to be extracted should have prominent facial surfaces.
- Willing to have the four premolars slightly flattened and smoothed.
- Willing to have all four premolars extracted for orthodontic reasons.
- Between 12 and 35 years of age.
- Willing to attend four appointments.
- Willing to wear a custom-made whitening tray during the evening when they sleep.
- Willing to have their premolars bleached with In-Office and At-Home bleaching agents and one of their teeth that will be extracted treated with phosphoric acid.
- Willing to sign a consent form (parents must co-sign if they are under 18).
- Willing to discontinue active orthodontic treatment during whitening treatment.
- Willing to brush at least twice a day with fluoridated toothpaste provided during the study.
- Exclusion criteria:
- Restorations or visible cavities in any tooth to be extracted.
- The presence of visible intraoral structural defects or pathology.
- Use of over-the-counter or professionally prescribed whitening agents in the past six months.
- Teeth with tetracycline staining.
- History of any medical illness that may interfere with the study or require special considerations.
- Pregnant or lactating women.
- Not willing to do the blood tests (biometrics hematic, prothrombin, and thromboplastin) prior to extractions (a legal requirement of the Oral Surgery Department of the UIC).
Exclusion
Key Trial Info
Start Date :
June 13 1924
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07165366
Start Date
June 13 1924
End Date
June 1 2025
Last Update
September 10 2025
Active Locations (1)
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1
Universidad Intercontinental
Mexico City, Tialpan, Mexico, 14420