Tooth BleachingNCT07569276
Effects of an Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
A study testing Propolis gel and KF2- Potassium nitrate in people with Tooth Bleaching and Pain, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- What is being tested?
- Propolis gel and KF2- Potassium nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Apr 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- good oral hygiene
- absence of active caries lesions
- never having previous whitening therapy
- not present dental hypersensitivity
- don't be a smoker
- not be pregnant
- present at least 28 teeth in the oral cavity.
Who cannot join
- volunteers who were under orthodontic treatment,
- presence of periodontal disease
- dental cracks or fractures
- restorations and prostheses on anterior teeth
- extensive molar restorations
- gastroesophageal disorders
- severe internal dental darkening
- presence of dentinal exposure in anterior and/or posterior teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
UFPA
Belém, Pará, 66075-110
University F Para, 55(91) 3201-7390, ppgo@ufpa.br
About this study
Official title: Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching. Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel. All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them. The bleaching agent will be applied for 30 minutes. The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes. Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1). The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.
Read the detailed description
All groups will undergo in-office whitening treatment, carried out in 2 sessions with a 7-day interval, according to the steps described below:
Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 30 minutes Final removal of the whitening gel and gingival barrier, followed by rinsing with water.
The application of the desensitizing agent or its placebo will follow this sequence:
Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.
- Conditions
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- Being tested
- Placebo - gel KY original, Propolis gel, KF2- Potassium nitrate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo - gel KY originalOther
Prior to bleaching treatment with 35% hydrogen peroxide, the Placebo group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
Propolis gelOther
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Propolis received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
KF2- Potassium nitrateOther
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo- KY original gel | Placebo comparator | The Placebo group received the application of placebo gel for post tooth bleaching sensitivity. Receives: Other: Placebo - gel KY original |
| KF2- Potassium nitrate | Active comparator | The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity. Receives: Other: KF2- Potassium nitrate |
| Propolis- Propolis 0,5% gel | Experimental | The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity. Receives: Other: Propolis gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-whitening sensitivity assessment
To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain. This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session. The assessment form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient\'s pain intensity level.
Measured: 14 days
Secondary outcomes (1)
Color evaluation
The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used to measure the color, where the area of dental correspondence to be evaluated will be the middle third of the vestibular surface of the upper canines. To standardize the color readings, silicone matrices will be made, where the impression will be extended from canine to canine. A window will be created on the vestibular surface of each canine of the silicone guide using a metal device with a radius of 6 mm, corresponding to the diameter of the spectrophotometer tip. Thus, the tip of the device will be inserted into the silicone guide to obtain the color parameters. Subsequently, the color difference between the baseline (T0) and one week after the 2rd bleaching session (T1) will be calculated using the CIEDE2000 formulas (ΔE00).
Measured: Baseline (T0) and one week after the 2rd whitening session (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start29 Apr 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth BleachingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
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
- NCT07569276
- Sponsor's protocol ID
- 93881125.4.0000.0018
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07569276
- Acronym / sponsor ID
- 93881125.4.0000.0018
- Conditions
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 29 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 6 May 2026 (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 randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching. Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel. All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them. The bleaching agent will be applied for 30 minutes. The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes. Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1). The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.
Detailed description
All groups will undergo in-office whitening treatment, carried out in 2 sessions with a 7-day interval, according to the steps described below:
Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 30 minutes Final removal of the whitening gel and gingival barrier, followed by rinsing with water.
The application of the desensitizing agent or its placebo will follow this sequence:
Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo- KY original gel | Placebo comparator | Other: Placebo - gel KY originalThe Placebo group received the application of placebo gel for post tooth bleaching sensitivity. |
| KF2- Potassium nitrate | Active comparator | Other: KF2- Potassium nitrateThe KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity. |
| Propolis- Propolis 0,5% gel | Experimental | Other: Propolis gelThe Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- good oral hygiene
- absence of active caries lesions
- never having previous whitening therapy
- not present dental hypersensitivity
- don't be a smoker
Key exclusion criteria (8 listed)
- volunteers who were under orthodontic treatment,
- presence of periodontal disease
- dental cracks or fractures
- restorations and prostheses on anterior teeth
- extensive molar restorations
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 |
|---|---|---|
| Placebo - gel KY originalPrior to bleaching treatment with 35% hydrogen peroxide, the Placebo group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. | Other | Placebo- KY original gel |
| Propolis gelPrior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Propolis received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes. | Other | Propolis- Propolis 0,5% gel |
| KF2- Potassium nitratePrior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes. | Other | KF2- Potassium nitrate |
Primary outcome
Post-whitening sensitivity assessment
Time frame: 14 days
To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain. This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session. The assessment form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient\'s pain intensity level.
1 secondary outcome
Color evaluation
Time frame: Baseline (T0) and one week after the 2rd whitening session (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis gel and KF2- Potassium nitrate in people with Tooth Bleaching and Pain, 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecy M Silva, Doctor (+55 (91) 3201-7563, cecymsilva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-whitening sensitivity assessment (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 6 May 2026.