Clinical trial NCT03089216: Combined Bleaching Technique: Efficacy and Tooth Sensitivity
Official title: Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Bleaching
Tooth Sensitivity
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).

Detailed description: This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .

After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.

Eligibility criteria: Inclusion Criteria:

* Upper and lower anterior teeth without restorations;
* Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).

Exclusion Criteria:

* Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
* Presence of non-carious lesions, such as abfraction, erosion and abrasion;
* Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
* Use of fixed orthodontic appliances;
* Presence of tooth sensitivity classified as equal to or greater than mild;
* Presence of severe dental dimming;
* Presence of parafunctional habits;
* Presence of any oral pathology;
* Smokers;
* pregnant and lactating women

Primary outcomes:
measure: Tooth Sensitivity (TS)
timeFrame: during bleaching, and up to 48 hours postbleaching
Secondary outcomes:
measure: Color Evaluation
timeFrame: The evaluations were performed in the baseline period and one month after the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Goias
name: Isabella N Favarão, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: