Clinical trial NCT03207204: In-office Bleaching Using a Violet Light
Official title: Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light (405-410 nm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Dentin Sensitivity
Keywords: Dental bleaching
Color
Sensitivity
violet LED
Quality of life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week); G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.

Detailed description: The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.

This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):

G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).

G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).

G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).

G4 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week).

G5 - In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week).

G6 - In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week).

G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week).

G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).

The primary outcome of this study is the color alteration, which will be evaluated quantitatively by colorimetric (subjective) and spectrophotometric (objective) tests. Additionally, will be evaluated dental sensitivity during and after treatment (predetermined times), patient satisfaction regarding the treatment, and impact on patient quality of life (questionnaire OHIP-14).

The color measurement will be blind, in predetermined times (before the treatment, immediately after the treatment, 14 days after, 3 months after, 6 months after and 12 months after). It will be performed by two methods: subjectively, with a color scale; and objectively, with a clinical spectrophotometer.

The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.

The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.

The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.

Eligibility criteria: Inclusion Criteria:

* Presence of all the teeth, without restorations or caries on anterior teeth.
* Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.

Exclusion Criteria:

* Patients presenting systemic pathologies
* Patients presenting periodontal diseases
* Smokers or patients with systematic use of alcohol
* Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
* Patients with historic of self-referenced sensitivity
* Pregnant or Breastfeeding period patients
* Presence of restorations on anterior teeth
* Patients presenting bruxism or systematic use of analgesics or anti-inflammatory drugs

Primary outcomes:
measure: Color alteration
timeFrame: 12 months after the treatment
Secondary outcomes:
measure: Dental sensitivity
timeFrame: Immediately after the treatment and 48 hours after the treatment
measure: Patient satisfaction regarding the treatment
timeFrame: 14 days after the end of treatment, 3 months after, 6 months after and 12 months after
measure: Quality of life of the patients
timeFrame: Immediately after the end of bleaching
measure: Color change throughout 12 months with a visual color scale
timeFrame: Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching
measure: Color change throughout 6 months with a clinical spectrophotometer
timeFrame: Before, immediately after, 14 days, 3 months and 6 months after bleaching
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Dentistry of USP
state: SP
Study officials:
affiliation: Associate Professor
name: Patricia Freitas, PhD
role: STUDY_CHAIR
References:
citation: Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
citation: Boushell LW, Ritter AV, Garland GE, Tiwana KK, Smith LR, Broome A, Leonard RH. Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment. J Esthet Restor Dent. 2012 Jun;24(3):211-9. doi: 10.1111/j.1708-8240.2011.00479.x. Epub 2011 Oct 11.