Healthy Volunteers, according to inclusion and non-inclusioncriteria
Conditions
Interventions
Comparative randomized clinical study aiming to prove the safety under normal conditions of use and the superiority of the whitening effectiveness for the combined use of the whitening strip+ photo ac
->Group II – 22 volunteers will use the whitening strip combined with the photo activator equipment.
The evaluation items for clinical and subjective efficacywill be whitening, brightness, removal of
Device
Other
E06.420.750
Sponsors
Basal Comércio, Importação e Exportação Ltda
Basal Comércio, Importação e Exportação Ltda
Medcin Instituto da Pele Ltda
Eligibility
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: Both male and female volunteers between 25 and 55 years old; Volunteers with dental indication for homemade teeth whitening; Intact buccal mucosa; Patient's agreement to follow the procedures of the study and be in the clinic on specific days and times; Reading, understanding, agreeing and signing of the patient on the Free and Informed Consent Term
Exclusion criteria
Exclusion criteria: Pregnancy; Lactation; Volunteers suffering from very sensitiveteeth with exposed cervical areas may limit the treatment or make it unfeasible; People with teeth severely stained by tetracycline grade III; People with teeth featuring enamel hypoplasia and white areas; Volunteers who fail to quit smoking during treatment; Volunteers with canker sores or mouth sores; Volunteers submitted to oral surgery in the last 03 months; People with teeth widely restored featuring surface shape, contour and/or texture changed; People with multiple erosion/abrasioninjuries; Volunteers with sensitivity in the cervical region of teeth; Active cancer or history of cancer in areas where the treatment will be carried out; History of collagen disorder, including keloid formation or history of poor wound healing; Any blood clotting disorder; History of immunosuppressive diseases (including HIV infection); Use of photosensitizing drugs; Patients with diabetes; Other conditions considered by the investigator as reasonable to disqualify the participation of the individual in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prove the superiority of the whitening efficacy for the combined use of the whitening strip+ photo activator equipment for the use of the whitening strip alone, based on the whitening evaluation, usinga 4-pointscale(1- Absent; 2 - Mild; 3 – Moderate; 4- Intense) after 21 days of continuous use carried out based on clinical evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prove the superiority of the whitening efficacy for the combined use of the whitening strip+ photo activator equipment for the use of the whitening strip alone, based on the following evaluations: -clinical evaluation of dental brightness improvement,using a 5-point scale (1 = Opaque and dull teeth, 2 = Slightly brightteeth, 3 = Moderately bright teeth, 4 = Very brightteeth, and 5 = Fully bright teeth) in the initial and final experimental times, where the expectation of improvement will be the increasing of the score after the use of the product, being it higher for the combined use. -clinical evaluation of the dental stainimprovement,using a 5-point scale (1 = Totally stained teeth, 2 = Moderately stained teeth, 3 = Very stained teeth,4 = Slightly stained teeth, 5 = Stainless teeth) in the initial and final experimental times, where the expectation of improvement will be the increasing of the score after the use of the product, being it higher for the combined use. -clinical evaluation of sensitivity after 21 days of continuous use,using a 4-pointscale (1 –Intense, 2 –Moderate; 3- Mild; 4 – Absent). -subjective evaluation of dental brightness after 21 days of use, using a 4-point scale (1 –Opaque. I haven´t noticeda bright effect; 2- Bright as they were before. I haven´t noticed any change; 3- Brighter; 4- Too bright. I have noticeda strong bright effect). -subjective evaluation of the removal of tooth stains after 21 days of use, using a 4-point scale (1- They are worse than before. They are still visible; 2 – They are the same as before, because they are still visible; 3 – They have been almost removed. They are not as visible as before; 4 – They have been completely removed. They are no longer visible). -subjective evaluation of dental sensitivity after 21 days of use, using a 4-point scale (1 – Intense, 2 – Moderate; 3 – Mild, 4 – Absent). | — |
Countries
Brazil
Contacts
Public ContactLeticia Souza
Basal Comércio, Importação e Exportação Ltda
Outcome results
None listed