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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05635253
Other study ID # UFPara-0014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date September 12, 2022

Study information

Verified date November 2022
Source Universidade Federal do Para
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial evaluated the influence of polishing on enamel color change after in-office bleaching treatment. It also evaluated the influence of polishing on tooth morphology and sensitivity.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 12, 2022
Est. primary completion date August 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Individuals aged 18 to 30 years old of both sexes; - With good oral hygiene; - With no sensitivity to tactile and evaporative stimuli; - Who have not undergone previous bleaching treatment, and with no caries lesions. Exclusion Criteria: - patients undergoing fixed orthodontic treatment; - patients allergic to the bleaching product; - drug users or pregnant women; - patients with carious lesions, defective restorations and/or periodontal disease, patients with systemic diseases, pulpitis or patients using analgesics.

Study Design


Intervention

Other:
Hydrogen Peroxide 35%
Group that received only bleaching treatment. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them.
Hydrogen Peroxide 35% + Polishing whitened teeth
Group that received only bleaching treatment followed by polishing. Soft tissue protection was performed with a Top Dam light-curing gingival barrier (FGM, Santa Catarina, SC, Brazil). Application of whitening gel (Whitness HP 35%/FGM) on the buccal surface from premolar to premolar in the upper and lower arches. Three 45-minute sessions were held with an interval of seven days between them. After bleaching, the vestibular surfaces were polished for 20s on each bleached tooth, with polishing paste and felt disc (Diamond Flex, FGM, Santa Catarina, SC, Brazil) in low rotation.

Locations

Country Name City State
Brazil Cecy Martins Silva Belém PA

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Influence of polishing on color after tooth whitening Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany) 14 days
Secondary Surface morphology of whitening enamel with and without polishing The images were obtained using a electron microscope (Mira3 model) with type electron gun, mounted on supports of aluminum with 12mm of diameter, using tape double adhesive carbon face, and metallic with Au for 2'30'' which deposits about the sample a film thick average of 10 to 15nm. The images were generated by detecting secondary electrons, using a voltage acceleration of 5 kV and a working distance of around 15 mm. 14 days
Secondary Influence of polishing on sensitivity after tooth whitening assessment of sensitivity during treatment using a visual analogue scale with values from 0 to 10, with higher values indicating a worse level of pain. 14 days
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