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

Discolored Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816593
• Other study ID #: FUMinasGerais01
• Status: Completed
• Phase: N/A
• First received: June 21, 2016
• Last updated: February 8, 2018
• Start date: August 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Discolored Teeth
• Tooth Discoloration

Intervention

Drug:
• hydrogen peroxide 6%
Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application
• hydrogen peroxide 15%
Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application
• Carbamide Peroxide 10%
Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Martín J, Vildósola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernández E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching—A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6. — View Citation

Meireles SS, Goettems ML, Dantas RV, Bona ÁD, Santos IS, Demarco FF. Changes in oral health related quality of life after dental bleaching in a double-blind randomized clinical trial. J Dent. 2014 Feb;42(2):114-21. doi: 10.1016/j.jdent.2013.11.022. Epub 2013 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of color change	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 ?E * = [(?L *) 2 + (?a *) 2 + (?b *) 2] 1/2.	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
Secondary	Tooth sensitivity assessment	It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.	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;
Secondary	Evaluation of gingival irritation	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.	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;
Secondary	Impact assessment on quality of life	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.	T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;