Evaluation of the Whitening Effect in Subjects After Professional Tooth Cleaning Procedure
ConditionTooth Color
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLacer S.A.
About this trial
The goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are:
• Does the toothpaste help to maintain teeth colour after professional cleaning?
Researchers will compare whitening toothpaste to a regular toothpaste to see if it works to maintain effects of professional teeth cleaning.
Participants will:
* Use assigned toothpaste daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check ups and evaluation
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy 55 subjects
Subjects of caucasian ethnicity
Subjects aged between 18 and 65 years (extremes included)
Subjects clinically showing stains on teeth (due to smoking, tea, coffee, wine or other food that typically stain teeth)
Disqualifiers
Subjects who do not meet the inclusion criteria.
Subjects with all affection which could interfere with the interpretation of the results of the study
Subjects planning toothcare during the study period, using dental apparatus
Subjects using dental prosthesis affecting the central superior incisors, with generalized tooth recession, malocclusion or overlapping teeth in the anterior region, with presence of caries, with dental abscess or untreated gum disease, with central superior incisor (tooth 11 or 21) evaluated and filled and who performed whitening treatments less than 6 months before the study begin
Trial design
Design model
Parallel
Treatments tested in this trial
Whitening toothpaste
Other interventionSubjects will use the whitening toothpaste 3 times daily during 4 weeks
Regular toothpaste
Other interventionSubjects will use the regular toothpaste 3 times daily during 4 weeks
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Whitening toothpasteExperimental treatment 1 intervention
Group B: Regular toothpasteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in teeth colour at by R20 Bleaching guide score at 4 weeks
The score ranges from 2 (lightest shade) to 40 (darkest shade). Improvement in colour means decrease in score number.
Time frame
From Baseline (after professional teeth cleaning) to end of use at 4 weeks.Secondary outcomes
1
Teeth brightness variation evaluated by score at 4 weeks
The brightness will be evaluated by the score from 1 to 4, where 1 means no variation and 4 means evidant improvement
Time frame
From Baseline (after professional teeth cleaning) to end of use at 4 weeks. Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: