- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635253
Influence of Polishing After Bleaching on Color Change and Enamel Morphology
November 29, 2022 updated by: Cecy Martins Silva, Universidade Federal do Para
Influence of Polishing After Bleaching on Color Change and Enamel Morphology: Randomized Clinical Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
PA
-
Belém, PA, Brazil, 66075-110
- Cecy Martins Silva
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: GROUP GSEM
In-office whitening treatment with 35% Hydrogen Peroxide
|
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.
|
Experimental: GROUP GP
In-office whitening treatment with 35% Hydrogen Peroxide + Polishing of 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of polishing on color after tooth whitening
Time Frame: 14 days
|
Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surface morphology of whitening enamel with and without polishing
Time Frame: 14 days
|
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
|
Influence of polishing on sensitivity after tooth whitening
Time Frame: 14 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2022
Primary Completion (Actual)
August 26, 2022
Study Completion (Actual)
September 12, 2022
Study Registration Dates
First Submitted
November 13, 2022
First Submitted That Met QC Criteria
November 29, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Actual)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 29, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFPara-0014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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