Clinical Evaluation of Enamel Microhardness Using Tooth Whitening Agents
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.
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 recruited from the Universidad Intercontinental (UIC) Graduate Program in Orthodontics, and private orthodontist dental offices in the city of Mexico. Patients who identify as needing extraction of the four first or second permanent premolars and who meet the following inclusion criteria will be invited to participate in the study.
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).
Treatment plan:
The study will be approved by Ultradent Products, Inc. and the Health Sciences Divisional Area Bioethics Committee, which is the equivalent of the Institutional Review Board (IRB) of UIC before any patients will be evaluated for eligibility to enter the study.
At the first appointment (selection appointment), the absence of evident cavities or restorations in the four premolars will be clinically verified with an intraoral mirror. Root formation will be confirmed with the panoramic radiograph from the patient's orthodontic chart. The treatment will be explained, and the patient will be allowed to ask questions and discuss any concerns. Subjects will be informed that the study will consist of 4 appointments. If the patient qualifies and agrees to be part of the study, they will be asked to sign an approved Consent Form. Parents or guardians will be asked to sign the consent form for patients under 18 years of age. Participants will be given a copy of the signed Consent Form. The requirements are that the four teeth that will be extracted for orthodontic reasons will be flattened and polished to produce a one-by-one millimeter surface on the facial or most prominent surface. This will be done with a 169L bur and fine and extra-fine sandpaper discs. Additionally, they must agree to use a whitening tray every night for 14 nights with Opalescence 10% CP with or without PF (potassium nitrate and fluoride) on an upper right premolar (UR) or on the upper left premolar (UL) (the tooth that has the best alignment). The contralateral lower right (LR) or lower left (LL) premolar will be treated with 40% hydrogen peroxide (HP) Opalescent Boost PF at the dental clinic for three 20-minute periods according to the manufacturer's instructions\*\*. Thirty of the 40 subjects will treat their UR or UL premolar treated with Opalescence 10% CP with PF. The remaining 10 subjects will treat their UR or UL premolar with Opalescence 10% CP without PF.
official title
Clinical Evaluation of Enamel Microhardness Using At-Home and In-Office Tooth Whitening Agents