after-bleaching sensitivity, quality of life
Conditions
Interventions
Test group: 35 subjects will be instructed to brush their teeth at least three times daily with a desensitizing dentifrice containing 5% potassium nitrate and sodium fluoride, starting 15 days before
Drug
D27.505.696.663.850.014.640
Sponsors
Universidade Federal do Amazonas
Universidade Federal do Amazonas
Eligibility
Inclusion criteria
Inclusion criteria: with good oral health; anterosuperior teeth with vitality, free of cavities and restorations on the vestibular surface; they should be dissatisfied with the color of their teeth; they should have upper central incisors with coloration equal to or darker than A2, according to the Vita Classical color scale in order of luminosity.
Exclusion criteria
Exclusion criteria: stimulated or provoked dentin sensitivity; enamel cracks; dentinal exposures; severe intrinsic stains on the teeth (such as tetracycline or fluorosis); periodontal disease without treatment; using any anti-inflammatory, analgesic and antioxidant action drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Number of patients that report spontaneous pain in any moment of the bleaching protocol and up to 7 days post-bleaching, through self-report. This number will be presented as percentage of patients with tooth sensitivity and will be named absolute risk of tooth sensitivity.;Outcome 1: the was no difference between groups regarding absolute risk of after-bleaching dental sensitivity (percentage of patients that report spontaneous pain in any moment of the bleaching protocol and up to 7 days post-bleaching, through self-report).;Expected outcome 2: The primary outcome for assessing oral health-related quality of life (HRQoL) was the difference in mean QVRSB scores between the test and control groups, as measured by the Oral Health Impact Questionnaire -14 (OHIP-14 ), with a difference of less than or equal to 3.5 being considered between groups (with a standard deviation of 5).;Outcome 2: The primary outcome effectively observed for the HRQoL was a difference in the mean QVRSB scores (measured by the OHIP-14 instrument) between the test and control groups of 0.11, noting the equality between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 3: The secondary outcome effectively observed for the HRQoL was a difference in the mean QVRSB (measured by OHIP-Esthetic) mean scores between the test and control groups of 0.65; and a difference in the mean variation in the total QVRSB scores (measured by the OIDP instrument) between the test and control groups of 0.3, noting the equality between the groups.;Expected outcome 3: Secondary outcomes to assess oral health-related quality of life (HRQoL) were the difference in mean QVRSB scores between the test and control groups, as measured by the Oral Health Impact Questionnaire-Esthetic (OHIP-Esthetic) and Oral Impact in Daily Performances (OIDP). A difference of less than or equal to 3.5 (with standard deviation of 5) for OHIP-Esthetic was considered as equivalence between the groups, and a difference less than or equal to 0.8 (with a standard deviation of 0.8) for OIDP .;Expected outcome: The intensity of tooth sensitivity will be assessed using the visual analogue scale (VAS 0-10) and will be presented as means and standard deviations in different periods: time 0 (15 days prior to first session of dental bleaching); time 1 pre-bleaching (before the first bleaching session), time 1 pos-bleaching (after the first bleaching session), time 2 pre-bleaching ( prior to the 2nd bleaching session), time 2 post-bleaching (after the 2nd bleaching session), time 3 (15 days after the first bleaching session) and time 4 (30 days after the bleaching session). ;Outcome 1: There was no differences between groups regarding intensity of sensitivity. ;Expected outcome: The difference in color between the baseline condition and post-bleaching (1 week and 1 month) will be assessed by Vita Classical and Bleachedguide Vita shade guide as well as with the Vita Easyshade spectrophotometer. The data will be presented as means and standard deviations.;Outcome 2: Regarding color difference, a statistically significant difference was found between the initial and final condition for | — |
Countries
Brazil
Contacts
Public ContactAdriana Queiroz
Universidade Federal do Amazonas
Outcome results
None listed