Back to resultsInfluence of Polishing After Bleaching on Color Change and Enamel Morphology
Primary Purpose
Tooth Discoloration, Morphologic Change, Tooth Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrogen Peroxide 35%
Hydrogen Peroxide 35% + Polishing whitened teeth
Sponsored by
About this trial
This is an interventional prevention trial for Tooth Discoloration
Eligibility Criteria
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.
Sites / Locations
- Cecy Martins Silva
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
GROUP GSEM
GROUP GP
Arm Description
In-office whitening treatment with 35% Hydrogen Peroxide
In-office whitening treatment with 35% Hydrogen Peroxide + Polishing of whitened teeth
Outcomes
Primary Outcome Measures
Influence of polishing on color after tooth whitening
Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05635253
First Posted
November 13, 2022
Last Updated
November 29, 2022
Sponsor
Universidade Federal do Para
1. Study Identification
Unique Protocol Identification Number
NCT05635253
Brief Title
Influence of Polishing After Bleaching on Color Change and Enamel Morphology
Official Title
Influence of Polishing After Bleaching on Color Change and Enamel Morphology: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Morphologic Change, Tooth Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP GSEM
Arm Type
Other
Arm Description
In-office whitening treatment with 35% Hydrogen Peroxide
Arm Title
GROUP GP
Arm Type
Experimental
Arm Description
In-office whitening treatment with 35% Hydrogen Peroxide + Polishing of whitened teeth
Intervention Type
Other
Intervention Name(s)
Hydrogen Peroxide 35%
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hydrogen Peroxide 35% + Polishing whitened teeth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Influence of polishing on color after tooth whitening
Description
Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Surface morphology of whitening enamel with and without polishing
Description
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.
Time Frame
14 days
Title
Influence of polishing on sensitivity after tooth whitening
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Cecy Martins Silva
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil
12. IPD Sharing Statement
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Influence of Polishing After Bleaching on Color Change and Enamel Morphology
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