Potassium Nitrate and Post-bleaching Sensitivity
NCT03523598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2020-08-12
Summary
This study will determine the effectiveness of the use of desensitivity gels prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide and using different types of potassium nitrate. Materials and Methods: Seventy five patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2% or placebo gel application on vestibular surface and Toothpaste 15 days before start the bleaching procedure (group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste). The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval.
Tooth sensitivity will be assessed before, during and 24 hours after the procedure using analog visual and verbal scales. Color alteration will be assessed by a Vita Guide scale at the end of the last session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level and color shade will be subjected to the Friedman, Wilcoxon (α = 0.05). If necessary, multiple comparation will be done using Tukey's test.
Conditions
- Medicaments Substances in Therapeutic Use
Interventions
- OTHER
-
Placebo gel + Normal Toothpaste
* 15 days before and during the period of bleaching sessions: Tooth paste used will be normal (Colgate). * Teeth will be cleaned using rubber cups associated to pumice and water; * Relative isolation with roller cotton will be done; * Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.
- OTHER
-
Placebo Gel + Potassium Nitrate Toothpaste
* 15 days before and during the period of bleaching sessions: Tooth paste used will be normal tooth paste (Colgate). * Teeth will be cleaned using rubber cups associated to pumice and water; * Relative isolation with roller cotton will be done; * Prior to each bleaching session, the patients will receive the 5% Potassium Nitrate gel application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.
- OTHER
-
Potassium Nitrate Gel + Normal Toothpaste
* 15 days before and during the period of bleaching sessions: Tooth paste used will be Potassium Nitrate containing (Sensodyne). * Teeth will be cleaned using rubber cups associated to pumice and water; * Relative isolation with roller cotton will be done; * Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.
Sponsors & Collaborators
-
Johnny Alexandre Oliveira Tavares
collaborator UNKNOWN -
Universidade Federal de Sergipe
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 29 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-26
- Primary Completion
- 2018-06-01
- Completion
- 2018-09-01
Countries
- Brazil
Study Locations
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