Clinical Evaluation of Enamel Microhardness Using Tooth Whitening Agents

NCT07165366 | Completed Results DMC

• 1 other identifier: 1-2025 Enamel Hardness
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator will review the medical history taken by the participants' orthodontist that determined participants eligibility to participate in this study on the first appointment. If the investigator determines that the position and condition of participants' teeth meet the inclusion and exclusion criteria for participation in this study, the participant will be enrolled to participate in the study. Once accepted, a small area (1 mm) of the premolars will be flattened and polished. Next, participants upper teeth will be scanned to make an impression, and the bleaching tray will be made on it. None of these procedures are painful, nor do they require anesthesia. This first appointment will last about 60 minutes. At the second appointment, the initial color of the upper premolar to be bleached will be taken. Participants will also be given a personalized whitening tray, a container to store the tray when not in use, a tube of low-concentration teeth whitening agent, and a toothbrush and toothpaste. The investigator will show participants how to place the tray on the upper arch. Participants will wear it through the night for fourteen nights. Participants will be given a chart to mark every night when the tray is used and teeth are brushed. Investigators will call participants the next day and in 7 days to see if participants have had any problems putting the gel in the tray and using it. This appointment will last approximately 30 minutes. The third appointment will consist of the investigator isolating one of the lower premolars that will be extracted. Some gel will be applied to that tooth three times; each time, the gel will stay on participant's tooth for 20 minutes. If the soft tissue or tooth is sensitive, a soothing gel will be applied to relieve the discomfort. This appointment will last approximately 90 minutes. The fourth appointment will be 14 days after the at-home bleaching was done and the in-office bleaching was accomplished. During this appointment, a lower premolar might be etched for 15 seconds. At this appointment, the oral surgeon the participant's orthodontist recommends will extract the participant's teeth. That will be the final appointment. During these 14 days, participant must keep cleaning teeth every day at least twice a day.

Conditions

Dental Atraumatic Restorative Treatment

Keywords

enamel loss; demineralization

Outcome Measures

Primary Outcomes (1)

• Enamel Hardness

  Vickers hardness kg f/mm2 Baseline measurements: two nonbleached bicuspids in the dental arches. One first or second bicuspid in the maxillary arch was bleached with At-Home 10% Carbamide Peroxide and the contralateral bicuspid served as the control in the maxillary arch. One first or second bicuspid in the mandibular arch was bleached with In-Office 40% Hydrogen Peroxide and the other contralateral bicuspid in the mandibular arch served as the control. The control bicuspids served as the baseline measurements.

  one month

Study Arms (3)

Control

NO INTERVENTION

Teeth left untreated as control group.

OP 10% CP

EXPERIMENTAL

Teeth treated with 10% CP over a14 day span

Diagnostic Test: Carbamide Peroxide 10%

OP 40% HP

EXPERIMENTAL

Teeth treated with 40% Hydrogen Peroxide

Diagnostic Test: Hydrogen Peroxide

Interventions

Hydrogen Peroxide DIAGNOSTIC_TEST

treatment of 40% Hydrogen Peroxide

OP 40% HP

Carbamide Peroxide 10% DIAGNOSTIC_TEST

treatment over 14 days of 10% Carbamide Peroxide

OP 10% CP

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Intercontinental: collaborator
• Indiana University: collaborator
• Ultradent Products, Inc.: lead

Study Sites (1)

Universidad Intercontinental

Mexico City, Tialpan, 14420, Mexico

Location

Related Links

• Study Protocol

Results Point of Contact

• Title: Bruce A. Matis
• Organization: Indiana University

bmatis@iu.edu

3172012089

Study Officials

• Bruce A Matis, DDS, MSD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the mouth there are two bicuspids in each quadrant. One bicuspid in the maxillary arch was treated with 10% CP for 14 days. One bicuspid in the mandibular arch was treated with 40% HP. The other bicuspids in the other two quadrants were untreated, negative controls.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: June 13, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)