Clinical Evaluation of Enamel Microhardness Using Tooth Whitening Agents

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

Interventions

DIAGNOSTIC_TEST

Carbamide Peroxide 10%

treatment over 14 days of 10% Carbamide Peroxide

DIAGNOSTIC_TEST

Hydrogen Peroxide

treatment of 40% Hydrogen Peroxide

Sponsors & Collaborators

• Universidad Intercontinental

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Ultradent Products, Inc.

  lead INDUSTRY

Principal Investigators

• Bruce A Matis, DDS, MSD · Indiana University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-13

Primary Completion

2025-06-01

Completion

2025-06-01

Countries

• Mexico

Study Locations