Skip to content

Effect of Otosporin on the dental sensitivity of bleaching.

Effect of Otosporin on dental sensitivity induced by bleaching.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-86pszd
Enrollment
Unknown
Registered
2019-08-16
Start date
2019-05-06
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

Dentin Sensitivity.

Interventions

Before the intervention, the vial containing Otosporin (Farmoquímica, Rio de Janeiro, Rio de Janeiro, Brazil) (Hydrocortisone 0.323mg
neomycin sulphate 0.162mg
Polymyxin B sulphate 322.6 IU) and a vial containing placebo with the same color and viscosity characteristics as Otosporin, but without the active components. The study design will be "word-of-mouth"
Drug
E06.420.750

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients older than 18 years of age. Male and female. With good general and oral health. Teeth free of caries lesions. Have teeth in color A2 or darker according to the Vita Classical scale (Vita Zahnfabrik, Bad Säckingen, Germany) and that they agree with the informed consent term (TCLE).

Exclusion criteria

Exclusion criteria: Will be excluded volunteers who have already undergone dental bleaching. Who have dental prosthesis; previous dental sensitivity; severe dental dimming by pathologies or medications; fixed orthodontic appliance. Who are pregnant or breastfeeding and who are making continuous use of some medicine that reduces the sensitivity dental.

Design outcomes

Primary

MeasureTime frame
Expected outcome: Number of patients reporting spontaneous pain at some time during the dental bleaching technique and up to 48 hours after the procedure, through self-report. This number will be transformed into a percentage of patients with pain and will be called absolute risk of dental sensitivity.

Secondary

MeasureTime frame
Expected outcome: The intensity of dental sensitivity will be evaluated using the 5-point numerical scale (NRS 0-4) and the VAS analogue visual scale (0-10) and will be presented as mean and standard deviation at different periods (during tooth whitening , Up to 1 h, from 1 h to 24 h and from 24 to 48 h post-bleaching);Expected outcome: The color difference between the initial condition and 1 month after bleaching will be assessed using the Vita Classical and Vita Bleachedguide color scales and also with the Vita Easyshade spectrophotometer. The data will be presented in the form of means and standard deviations.

Countries

Brazil

Contacts

Public ContactAlessando Loguercio

Universidade Estadual de Ponta Grossa

aloguercio@hotmail.com+55-042-999029903

Outcome results

None listed

Source: REBEC (via WHO ICTRP)