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In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.

In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.: Effectiveness, Security and Impact on Quality of Life Related to Oral Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02816593
Enrollment
90
Registered
2016-06-28
Start date
2015-08-31
Completion date
2018-02-28
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discolored Teeth

Keywords

carbamide peroxide, Hydrogen peroxide, Quality of life

Brief summary

To evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.

Detailed description

The aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. It will be a randomized, parallel and single blind. Participants are divided into three groups (n = 30) according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 = Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth will be evaluated in seven different times, using the color scale Vita Master Classic 3D and spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. The impact of bleaching quality of life will be assessed using the Brazilian version of the oral impact on daily performance (OIDP). The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.

Interventions

DRUGhydrogen peroxide 6%

Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application

DRUGhydrogen peroxide 15%

Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application

Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* tooth color ranging from A3 or darker, teeth with no stains and restorations without whitening experience

Exclusion criteria

* participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of color changeT0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months ;T6:After 12 monthsVisual evaluation using color scale Vita Classical 3D Master (Vita Zahnfabrik, Germany); (B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4) Quantitative evaluation using a spectrophotometer Easy Shade Advance ® (Wilcos Brazil). System CIE L \* a \* b \* - L represents the value (lightness or darkness), the value of a \* is a measure red (positive a \*) or green (negative a \*); the value of b \* is a yellow extent (b \* positive) or blue (b \* negative) and the color difference between the color coordinate is calculated as ΔE \* = \[(ΔL \*) 2 + (Δa \*) 2 + (Δb \*) 2\] 1/2.

Secondary

MeasureTime frameDescription
Tooth sensitivity assessmentT0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.
Evaluation of gingival irritationT0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;The Modified Gingival Index (IGM) The criteria are as follows: 0: Absence of inflammation;1: mild inflammation - slight change in color and texture of the gum; 2: mild inflammation involving the entire gingival margin; 3: moderate inflammation, shiny surface and edema; 4: Severe inflammation, spontaneous bleeding and severe edema.
Impact assessment on quality of lifeT0 (Baseline): Before treatment;T4: After 30 days of starting treatment;The Brazilian version of the oral impact on daily performance (OIDP) will be used to assess the impact on quality of life. The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4) to assess the perception of changes in oral health after treatment.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026