Tooth BleachingNCT07599514
Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity
A study testing KF2 - Potassium nitrate and Jucá - Libidibia ferrea gel in people with Tooth Bleaching and Pain, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, parallel, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy. 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?
- KF2 - Potassium nitrate and Jucá - Libidibia ferrea gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jun 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; No previous tooth bleaching treatment; Absence of dental hypersensitivity; Not being pregnant; Presence of at least 28 teeth in the oral cavity.
Who cannot join
- Volunteers undergoing orthodontic treatment; Presence of periodontal disease; Dental cracks or fractures; Restorations or prostheses on anterior teeth; Extensive restorations in molars; Gastroesophageal disorders; Severe intrinsic tooth discoloration; Presence of dentin 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
Federal University of Pará, 55(91) 3201-7390, ppgo@ufpa.br
About this study
Official title: Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.
This randomized, parallel, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy. Seventy-five selected volunteers will be randomly allocated into three groups: CT (placebo gel), KF2 (5% potassium nitrate and 2% sodium fluoride), and JUC (experimental Libidibia ferrea gel). Each group will receive the corresponding desensitizing treatment, and the assigned product will be actively applied to the labial surfaces of the anterior teeth and the buccal surfaces of the first premolars for 10 minutes. Subsequently, all groups will undergo an in-office tooth bleaching protocol with 35% hydrogen peroxide, consisting of two sessions with three 15-minute applications each, with a 7-day interval between sessions. Postoperative sensitivity will be recorded daily by the patients for 14 days using a visual analog scale (VAS), while tooth color will be measured using a spectrophotometer at baseline and one week after the end of treatment. Data will be subjected to statistical analysis according to sample distribution, with a statistical power of 80% and a significance level of 5%.
Read the detailed description
All groups will undergo in-office tooth bleaching treatment, performed in two sessions with a 7-day interval, according to the steps described below: prophylaxis; application of the desensitizing agent or placebo, according to the assigned group, for 10 minutes; rinsing with water; application of the gingival barrier; application of Whiteness HP 35% bleaching gel for 45 minutes, consisting of three 15-minute applications; final removal of the bleaching gel and gingival barrier, followed by rinsing with water. A lip retractor will be used during the application of the desensitizing agent or placebo and throughout the bleaching procedure. The assigned product will be actively applied using a microbrush.
- Conditions
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- Being tested
- Placebo, KF2 - Potassium nitrate, Jucá - Libidibia ferrea gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Before bleaching treatment with 35% hydrogen peroxide, participants in the placebo group received a placebo gel without active ingredients, applied under the same conditions described for the experimental gel.
KF2 - Potassium nitrateOther
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the KF2 group will receive an application of a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
Jucá - Libidibia ferrea gelOther
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the Jucá group will receive an application of the experimental 0.5% Libidibia ferrea gel on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity. Receives: Other: Placebo |
| KF2 - Potassium nitrate | Active comparator | The KF2 group received an application of 5% potassium nitrate and 2% sodium fluoride for the control of post-bleaching tooth sensitivity. Receives: Other: KF2 - Potassium nitrate |
| Jucá - Libidibia ferrea gel | Experimental | The Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity. Receives: Other: Jucá - Libidibia ferrea gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-whitening sensitivity assessment
To assess postoperative sensitivity, patients will be instructed to complete a form to record daily tooth sensitivity during the 14-day treatment period, based on their individual perception of pain. This form will be provided at each bleaching session and returned to the researcher at the following session, that is, one week after each bleaching session. The assessment form will include a visual analog scale (VAS), consisting of a 10-cm horizontal line with scores of 0 and 10 at its ends, where 0 indicates no sensitivity and 10 indicates severe tooth sensitivity. Patients will be instructed to draw a vertical mark along the horizontal line of the scale to record the intensity of tooth sensitivity each day. Subsequently, the distance in millimeters from the zero endpoint will be measured using a millimeter ruler, thereby obtaining the patient's pain intensity score.
Measured: 14 days
Secondary outcomes (1)
Color evaluation
The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used for color measurement. The evaluated tooth area will be the middle third of the labial surface of the maxillary canines. To standardize color readings, silicone matrices will be fabricated, with the impression extending from canine to canine. A window will be created on the labial surface of each canine in the silicone guide using a metal device with a 6-mm diameter, 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 baseline (T0) and one week after the second bleaching session (T1) will be calculated using the CIEDE2000 formula (ΔE00).
Measured: Baseline (T0) and one week after the second bleaching session (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 Jun 2026 (estimated)
- Primary completion30 Jan 2027 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 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
- NCT07599514
- Sponsor's protocol ID
- 95040526.4.0000.0018
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 22 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07599514
- Acronym / sponsor ID
- 95040526.4.0000.0018
- Conditions
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 13 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 20 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, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy. Seventy-five selected volunteers will be randomly allocated into three groups: CT (placebo gel), KF2 (5% potassium nitrate and 2% sodium fluoride), and JUC (experimental Libidibia ferrea gel). Each group will receive the corresponding desensitizing treatment, and the assigned product will be actively applied to the labial surfaces of the anterior teeth and the buccal surfaces of the first premolars for 10 minutes. Subsequently, all groups will undergo an in-office tooth bleaching protocol with 35% hydrogen peroxide, consisting of two sessions with three 15-minute applications each, with a 7-day interval between sessions. Postoperative sensitivity will be recorded daily by the patients for 14 days using a visual analog scale (VAS), while tooth color will be measured using a spectrophotometer at baseline and one week after the end of treatment. Data will be subjected to statistical analysis according to sample distribution, with a statistical power of 80% and a significance level of 5%.
Detailed description
All groups will undergo in-office tooth bleaching treatment, performed in two sessions with a 7-day interval, according to the steps described below: prophylaxis; application of the desensitizing agent or placebo, according to the assigned group, for 10 minutes; rinsing with water; application of the gingival barrier; application of Whiteness HP 35% bleaching gel for 45 minutes, consisting of three 15-minute applications; final removal of the bleaching gel and gingival barrier, followed by rinsing with water. A lip retractor will be used during the application of the desensitizing agent or placebo and throughout the bleaching procedure. The assigned product will be actively applied using a microbrush.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity. |
| KF2 - Potassium nitrate | Active comparator | Other: KF2 - Potassium nitrateThe KF2 group received an application of 5% potassium nitrate and 2% sodium fluoride for the control of post-bleaching tooth sensitivity. |
| Jucá - Libidibia ferrea gel | Experimental | Other: Jucá - Libidibia ferrea gelThe Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good oral hygiene; Absence of active caries lesions; No previous tooth bleaching treatment; Absence of dental hypersensitivity; Not being pregnant; Presence of at least 28 teeth in the oral cavity.
Key exclusion criteria (1 listed)
- Volunteers undergoing orthodontic treatment; Presence of periodontal disease; Dental cracks or fractures; Restorations or prostheses on anterior teeth; Extensive restorations in molars; Gastroesophageal disorders; Severe intrinsic tooth discoloration; Presence of dentin exposure in anterior and/or posterior teeth.
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 |
|---|---|---|
| PlaceboBefore bleaching treatment with 35% hydrogen peroxide, participants in the placebo group received a placebo gel without active ingredients, applied under the same conditions described for the experimental gel. | Other | Placebo |
| KF2 - Potassium nitratePrior to bleaching treatment with 35% hydrogen peroxide, participants in the KF2 group will receive an application of a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes. | Other | KF2 - Potassium nitrate |
| Jucá - Libidibia ferrea gelPrior to bleaching treatment with 35% hydrogen peroxide, participants in the Jucá group will receive an application of the experimental 0.5% Libidibia ferrea gel on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes. | Other | Jucá - Libidibia ferrea gel |
Primary outcome
Post-whitening sensitivity assessment
Time frame: 14 days
To assess postoperative sensitivity, patients will be instructed to complete a form to record daily tooth sensitivity during the 14-day treatment period, based on their individual perception of pain. This form will be provided at each bleaching session and returned to the researcher at the following session, that is, one week after each bleaching session. The assessment form will include a visual analog scale (VAS), consisting of a 10-cm horizontal line with scores of 0 and 10 at its ends, where 0 indicates no sensitivity and 10 indicates severe tooth sensitivity. Patients will be instructed to draw a vertical mark along the horizontal line of the scale to record the intensity of tooth sensitivity each day. Subsequently, the distance in millimeters from the zero endpoint will be measured using a millimeter ruler, thereby obtaining the patient's pain intensity score.
1 secondary outcome
Color evaluation
Time frame: Baseline (T0) and one week after the second bleaching 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 22 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 KF2 - Potassium nitrate and Jucá - Libidibia ferrea gel 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 1 inclusion and 1 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 22 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 (+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 22 May 2026.