Tooth BleachingNCT06614764
Effect of Andiroba on Control of Post-whitening Tooth Sensitivity
A study testing AG (experimental Andiroba Gel) and KF2G (Potassium nitrate gel) in people with Tooth Bleaching and Pain, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. 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?
- AG (experimental Andiroba Gel) and KF2G (Potassium nitrate gel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2024to 30 Nov 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- good oral hygiene
- absence of active caries lesions
- never having undergone 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.
About this study
Official title: Effect of Andiroba on Control of Post-whitening Tooth Sensitivity: a Randomized Clinical Trial
This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).
Read the detailed description
All groups will undergo in-office whitening treatment, carried out in 3 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 15 minutes each, totaling 45 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
- AG (experimental Andiroba Gel), KF2G (Potassium nitrate gel), PG (Placebo Gel)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG (experimental Andiroba Gel)Other
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the AG received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.
KF2G (Potassium nitrate gel)Other
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2G received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.
PG (Placebo Gel)Other
Prior to bleaching treatment with 35% hydrogen peroxide, the PG group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
| Study group | Role | What they receive |
|---|---|---|
| PG- Placebo gel | Placebo comparator | The PG group received the application of placebo gel for post tooth bleaching sensitivity. Receives: Other: PG (Placebo Gel) |
| GKF2- Potassium nitrate | Active comparator | The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity. Receives: Other: KF2G (Potassium nitrate gel) |
| AG- Andiroba Gel | Experimental | The AG group received the application of experimental gel of andiroba (Carapa guianensis) for post tooth bleaching sensitivity. Receives: Other: AG (experimental Andiroba 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 21 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: Period: 21 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 3rd bleaching session (T1) will be calculated using the CIEDE2000 formulas (ΔE00).
Measured: Baseline (Ti) and one week after the 3rd whitening session (Tf).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
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
- Investigator
- Enrolment
- 75 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
- Investigators
- Cecy M Silva, doctor, Principal investigator, Universidade federal do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614764
- Sponsor's protocol ID
- 81021724.2.0000.0018
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Andiroba on Control of Post-whitening Tooth Sensitivity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06614764
- Acronym / sponsor ID
- 81021724.2.0000.0018
- Conditions
- Tooth Bleaching, Pain, Dentin Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Sep 2024 (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 clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).
Detailed description
All groups will undergo in-office whitening treatment, carried out in 3 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 15 minutes each, totaling 45 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
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PG- Placebo gel | Placebo comparator | Other: PG (Placebo Gel)The PG group received the application of placebo gel for post tooth bleaching sensitivity. |
| GKF2- Potassium nitrate | Active comparator | Other: KF2G (Potassium nitrate gel)The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity. |
| AG- Andiroba Gel | Experimental | Other: AG (experimental Andiroba Gel)The AG group received the application of experimental gel of andiroba (Carapa guianensis) 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 undergone 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 |
|---|---|---|
| AG (experimental Andiroba Gel)Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the AG received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. | Other | AG- Andiroba Gel |
| KF2G (Potassium nitrate gel)Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2G received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. | Other | GKF2- Potassium nitrate |
| PG (Placebo Gel)Prior to bleaching treatment with 35% hydrogen peroxide, the PG group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. | Other | PG- Placebo gel |
Primary outcome
Post-whitening sensitivity assessment
Time frame: Period: 21 days
To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 21 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 (Ti) and one week after the 3rd whitening session (Tf).
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 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Tooth Bleaching
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Not yet recruiting
Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching
Discolored Teeth
Enrolling by invitation
Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
Bleaching; Satisfactory, Bleaching Sensitivity
Recruiting
Oil Pulling Whitening Mouthwash
Healthy Adult Participants, Tooth Stain
Not yet recruiting
Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity
Tooth Bleaching, Pain
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.
Cecy M Silva, doctor principal investigator
Universidade federal do Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AG (experimental Andiroba Gel) and KF2G (Potassium nitrate 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 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: finished, as of the sponsor's last update on 30 Mar 2025. 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?
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?
Post-whitening sensitivity assessment (time frame: Period: 21 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 30 Mar 2025.