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Discolored TeethNCT02816593

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

A study testing hydrogen peroxide 6%, hydrogen peroxide 15% and Carbamide Peroxide 10% in people with Discolored Teeth, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Discolored Teeth
What is being tested?
hydrogen peroxide 6%, hydrogen peroxide 15% and Carbamide Peroxide 10%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteBrazil
Study dates
Aug 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Minas Gerais

    Belo Horizonte, Minas Gerais

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
hydrogen peroxide 6%, hydrogen peroxide 15%, Carbamide Peroxide 10%
Keywords
carbamide peroxide, Hydrogen peroxide, Quality of life
Medical subject headings
Tooth Discoloration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydrogen peroxide 6%Drug

    Also called Group 1 - HP 6%

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

  • hydrogen peroxide 15%Drug

    Also called Group 2 - HP 15%

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

  • Carbamide Peroxide 10%Drug

    Also called Group 3 - CP 10%

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

Study groups in NCT02816593
Study groupRoleWhat they receive
Group 1 - HP 6%ExperimentalGroup 1: Experimental: Office; hydrogen peroxide 6%,
Receives: Drug: hydrogen peroxide 6%
Group 2 - HP 15%ExperimentalGroup 2: Experimental: Office; hydrogen peroxide 15%,
Receives: Drug: hydrogen peroxide 15%
Group 3 - CP 10%Active comparatorGroup 3: Control: Homemade; Carbamide Peroxide 10%,
Receives: Drug: Carbamide Peroxide 10%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ΔE * = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2] 1/2.

    Measured: 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 outcomes (3)

  1. Tooth sensitivity assessment

    It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.

    Measured: 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;

  2. 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.

    Measured: 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;

  3. 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.

    Measured: T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2017
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02816593
Sponsor's protocol ID
FUMinasGerais01
Status last verified
Feb 2018
First submitted
21 Jun 2016
Last updated
12 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Martin J, Vildosola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernandez 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.

    PubMed 26057085

  • Meireles SS, Goettems ML, Dantas RV, Bona AD, 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.

    PubMed 24316342

Questions about this trial

What is this clinical trial studying?

A study testing hydrogen peroxide 6%, hydrogen peroxide 15% and Carbamide Peroxide 10% in people with Discolored Teeth, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02816593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.

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