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Clinical performance of whitening toothpaste

Clínical performance of a new Whitening Dentifrice containing optimized abrasive particles, desensitizing agent and dyes for optical whitening effect - Clínical Randomized Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-34r4dz
Enrollment
Unknown
Registered
2017-08-24
Start date
2017-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Mottled Teeth

Interventions

Two dental gels will be tested, with a test (Dental Whitening / Sanifil Gel) and a control (Mental Dental Gel / Sanifil), in which we will evaluate the effectiveness, through three parameters: of teet
Group 2: mint gel (control), this group will be composed of half of the volunteers, who will use the peppermint gel exclusively for 30 days. In the initial consultation (T0-baseline), volunteers will
E06.420.750

Sponsors

Faculdade de Odontologia de Araraquara
Lead Sponsor
Faculdade de Odontologia de Araraquara
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers of both genders; over 18 years of age; who have at least 20 natural teeth in the oral cavity; and at least 6 incisors and Superior canines without caries; restorations or prostheses.

Exclusion criteria

Exclusion criteria: Pregnant women and infants will be excluded from the study; and volunteers with systemic diseases; xerostomia; acid erosion; bruxism; touth breathing; dental crowding and orthodontic treatment.

Design outcomes

Primary

MeasureTime frame
To evaluate whether the clinical performance of a bleaching dentifrice composed of abrasive particles of optimized silica, desensitizing agent and optical effect dyes is different from that promoted by a conventional dentifrice. The efficacy of bleaching will be given by the difference between the color of the upper and upper central incisors before and after each period of use of the dental gels, being evaluated using VITA EasyShade Vivadent Spectrophotometer, also using ScanWhite software, by visual comparison Using the Vita Classical scale and the participant's visual self-assessment using the Vita Classical scale. The ability to reduce staining of the dental surface will be assessed by the Modified Lobene Dental Stain Index made by a calibrated examiner, having scores for each of the 4 areas of the buccal surface of the evaluated elements (central and upper canines), evaluating both the extent of surface spotting. The discomfort will be determined by the evaluation of the cervical dentinal sensitivity and by the side effects, where the sensitivity will be evaluated by the trained, calibrated and blinded examiner for which treatment was used, doing two clinical tests: evaporative thermometer assisted by the triple syringe, using its jet of Air in the cervical region of the evaluated elements; And pressure test, done with an exploratory catheter also in the cervical region of the evaluated teeth. Both the evaporative and pressure thermal tests will be self-recorded by the participant in the visual analogue scale, with a score of 0 to 10, the level of sensitivity will be given by the difference between the sensitivity recorded at baseline and at the end of the study. The side effects, if any, will be recorded according to their intensity, on a scale of 0 to 3, where 0 is absent, 1 is mild, 2 moderate and 3 is severe. The evaluation time for this study will be 30 days, where it will be divided into: Baseline (T0), Immediately after the first use of the gel (T1), sev

Secondary

MeasureTime frame
To evaluate patients' satisfaction with the use of bleaching toothpaste, through the application of a questionnaire on the psychosocial impact of dental aesthetics (PIDAQ), baseline and treatment (30 days).

Countries

Brazil

Contacts

Public ContactOsmir Oliveira Júnior

Faculdade de Odontologia de Araraquara

drosmirde@hotmail.com+55(16)33016520

Outcome results

None listed

Source: REBEC (via WHO ICTRP)