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Completed

NCT Number: NCT02816593

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

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.

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Key information

Conditions

Discolored Teeth Stomatognathic Diseases Tooth Discoloration Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hydrogen peroxide 6%

Drug

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

Other names: Group 1 - HP 6%

hydrogen peroxide 15%

Drug

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

Other names: Group 2 - HP 15%

Carbamide peroxide 10%

Drug

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

Other names: Group 3 - CP 10%

Primary outcomes

  1. Evaluation of color change

    Time frame: T0 (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 months

    Visual 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 outcomes

  1. Tooth sensitivity assessment

    Time frame: T0 (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.

  2. Evaluation of gingival irritation

    Time frame: T0 (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.

  3. Impact assessment on quality of life

    Time frame: T0 (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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 28, 2016
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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