Tooth DiscolorationNCT05635253
Influence of Polishing After Bleaching on Color Change and Enamel Morphology
A study testing Hydrogen Peroxide 35% and Hydrogen Peroxide 35% + Polishing whitened teeth in people with Tooth Discoloration and Morphologic Change, run by Universidade Federal do Para at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Morphologic Change, Tooth Sensitivity
- What is being tested?
- Hydrogen Peroxide 35% and Hydrogen Peroxide 35% + Polishing whitened teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Discoloration, Morphologic Change, Tooth Sensitivity
- Being tested
- Hydrogen Peroxide 35%, Hydrogen Peroxide 35% + Polishing whitened teeth
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Peroxide 35%Other
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 teethOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP GSEM | Other | In-office whitening treatment with 35% Hydrogen Peroxide Receives: Other: Hydrogen Peroxide 35% |
| GROUP GP | Experimental | In-office whitening treatment with 35% Hydrogen Peroxide + Polishing of whitened teeth Receives: Other: Hydrogen Peroxide 35% + Polishing whitened teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of polishing on color after tooth whitening
Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)
Measured: 14 days
Secondary outcomes (2)
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.
Measured: 14 days
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start10 Jan 2022
- Primary completion26 Aug 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635253
- Sponsor's protocol ID
- UFPara-0014
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Polishing After Bleaching on Color Change and Enamel Morphology: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05635253
- Acronym / sponsor ID
- UFPara-0014
- Conditions
- Tooth Discoloration, Morphologic Change, Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP GSEM | Other | Other: Hydrogen Peroxide 35%In-office whitening treatment with 35% Hydrogen Peroxide |
| GROUP GP | Experimental | Other: Hydrogen Peroxide 35% + Polishing whitened teethIn-office whitening treatment with 35% Hydrogen Peroxide + Polishing of whitened teeth |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | GROUP GSEM |
| Hydrogen Peroxide 35% + Polishing whitened teethGroup 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. | Other | GROUP GP |
Primary outcome
Influence of polishing on color after tooth whitening
Time frame: 14 days
Color evaluation was performed with the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany)
2 secondary outcomes
Surface morphology of whitening enamel with and without polishing
Time frame: 14 days
Influence of polishing on sensitivity after tooth whitening
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen Peroxide 35% and Hydrogen Peroxide 35% + Polishing whitened teeth in people with Tooth Discoloration and Morphologic Change, run by Universidade Federal do Para at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of polishing on color after tooth whitening (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.