Dentin SensitivityPhase 1NCT07027566
Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity
A Phase 1 study testing Potassium nitrate and sodium fluoride, Cannabidiol (CBD) Gel and Natrosol 4% Gel in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
The goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (CBD) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (HP). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Potassium nitrate and sodium fluoride, Cannabidiol (CBD) Gel and Natrosol 4% Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jul 2025to Jul 2026
- Phase
- Phase 1
- 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
- Participants must have at least 28 teeth in the cavity
- Good oral and general health
Who cannot join
- active caries or periodontal disease
- visible cracks in front teeth upper or lower
- with evident malocclusion
- restorations and prosthetics in teeth anterior teeth
- gastroesophageal disorders
- severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
Show all 11Show fewer
- dentin exposure in anterior teeth and /or later
- parafunctional habits
- tooth sensitivity
- whitening treatment prior to or undergoing orthodontic treatment
- Furthermore, smokers, pregnant or breastfeeding women do not will be included.
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
Federal University of Pará School of Dentistry
Belém, Pará, 66075-110
Sandro C Loretto, PHD, 55 91 8122-3477, sandroloretto@hotmail.com
Cecy M Silva, PHD
About this study
Official title: Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching
The goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (CBD) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (HP). Volunteers will be selected and allocated to the following groups: GP - placebo gel, GCBD - experimental cannabidiol gel and GKF - Potassium Nitrate and Sodium Fluoride Gel. In each group, the corresponding desensitizing gel will be applied to on the teeth for 10 minutes. All groups will then undergo in-office whitening treatment with 35% hydrogen peroxide. Patients will be instructed to record tooth sensitivity on a daily basis during the 21 days of follow-up. Pain intensity will be measured using a visual analog scale (VAS), while the risk of developing sensitivity will be recorded after each session of the whitening procedure, with two response option.
- Conditions
- Dentin Sensitivity
- Being tested
- Potassium nitrate and sodium fluoride, Cannabidiol (CBD) Gel, Natrosol 4% Gel
- Keywords
- Tooth Bleaching, Cannabidiol, Dentin Sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium nitrate and sodium fluorideDrug
Also called GC
Gel with 5% potassium nitrate and 2% sodium fluoride gel of 5% potassium nitrate and 2% sodium fluoride for topical application to teeth before bleaching with hydrogen peroxide
Cannabidiol (CBD) GelDrug
Also called GCBD
Cannabidiol gel for teeth ( 2% cannabidiol oil) before bleaching with hydrogen peroxide
Natrosol 4% GelDrug
Also called GP
placebo gel (natrosol-based gel 4%) for topical application to teeth before bleaching with hydrogen peroxide.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | The placebo gel (PG) (natrosol 4%) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany)) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf). Receives: Drug: Natrosol 4% Gel |
| Control group | Active comparator | gel with 5% potassium nitrate and 2% sodium fluoride The gel with 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two Receives: Drug: Potassium nitrate and sodium fluoride |
| Experimental group | Experimental | The experimental 2% cannabidiol gel (GCBD) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with an active microbrush, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of followup. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf). Receives: Drug: Cannabidiol (CBD) Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening
Experimental cannabidiol and gel (experimental group) and potassium nitrate gel (control group) can change sensitivity related to tooth whitening with hydrogen peroxide 35%. So it is necessary measure this pain. The volunteers will mark on the scale (VAS) the level (1-10) of sensitivity immediately after the intervention, and for a period of 21 days of treatment.
Measured: immediately after the intervention, and for a period of 21 days of treatment
Secondary outcomes (1)
Change in Color of Teeth Bleached by spectrophotometer (VITA Easyshade)(quantitative method: (ΔE00)
Silicone trays will be made, with canine-by-canine impressions. 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. The tip of the device will be inserted into the silicone guide to obtain the color parameters of the CIEL*a*b* system, where L* represents the value (light or dark); a* is a measurement of red (a* positive) or green (a* negative); b* is a measurement of yellow (b* positive) or blue (b* negative). The sum of the measured values of the upper canines will be used to obtain the averages of each L*a*b* coordinate for each patient. ΔL*, Δa* and Δb* will be calculated by the difference between the time intervals. Subsequently, the color difference between baseline (Ti) and one week after the 3rd bleaching session (Tf) will be calculated using the CIEDE2000 formulas (ΔE00).
Measured: There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start25 Jul 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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 1
- Primary purpose
- Prevention
- 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, Jesuína Lamartine Nogueira Araújo, Universidade Federal do Para
- Investigators
- Jesuína L Nogueira Araújo, PHD, Principal investigator, Federal University of Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027566
- Sponsor's protocol ID
- PPGOUFPAFO
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Brazilian legislation (LGPD), 13.709/2018
Publications
Sano IS, de Almeida AS, Xavier GMB, Paes YFO, Silva CM, de Freitas MCC, da Costa RS, Araujo JLN. Synthesis of an experimental gel containing cannabidiol oil and evaluation of effects on bleached bovine enamel. Odontology. 2026 Jan;114(1):108-120. doi: 10.1007/s10266-025-01105-5. Epub 2025 Apr 19.
PubMed 40253312
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching
- ClinicalTrials.gov ID
- NCT07027566
- Acronym / sponsor ID
- PPGOUFPAFO
- Conditions
- Dentin Sensitivity
- Keywords
- Tooth Bleaching, Cannabidiol, Dentin Sensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jun 2025 (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.
The goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (CBD) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (HP). Volunteers will be selected and allocated to the following groups: GP - placebo gel, GCBD - experimental cannabidiol gel and GKF - Potassium Nitrate and Sodium Fluoride Gel. In each group, the corresponding desensitizing gel will be applied to on the teeth for 10 minutes. All groups will then undergo in-office whitening treatment with 35% hydrogen peroxide. Patients will be instructed to record tooth sensitivity on a daily basis during the 21 days of follow-up. Pain intensity will be measured using a visual analog scale (VAS), while the risk of developing sensitivity will be recorded after each session of the whitening procedure, with two response option.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Natrosol 4% GelThe placebo gel (PG) (natrosol 4%) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany)) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf). |
| Control group | Active comparator | Drug: Potassium nitrate and sodium fluoridegel with 5% potassium nitrate and 2% sodium fluoride The gel with 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two |
| Experimental group | Experimental | Drug: Cannabidiol (CBD) GelThe experimental 2% cannabidiol gel (GCBD) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with an active microbrush, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of followup. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must have at least 28 teeth in the cavity
- Good oral and general health
Key exclusion criteria (11 listed)
- active caries or periodontal disease
- visible cracks in front teeth upper or lower
- with evident malocclusion
- restorations and prosthetics in teeth anterior teeth
- gastroesophageal disorders
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 |
|---|---|---|
| Potassium nitrate and sodium fluorideAlso: GCGel with 5% potassium nitrate and 2% sodium fluoride gel of 5% potassium nitrate and 2% sodium fluoride for topical application to teeth before bleaching with hydrogen peroxide | Drug | Control group |
| Cannabidiol (CBD) GelAlso: GCBDCannabidiol gel for teeth ( 2% cannabidiol oil) before bleaching with hydrogen peroxide | Drug | Experimental group |
| Natrosol 4% GelAlso: GPplacebo gel (natrosol-based gel 4%) for topical application to teeth before bleaching with hydrogen peroxide. | Drug | Placebo group |
Primary outcome
Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening
Time frame: immediately after the intervention, and for a period of 21 days of treatment
Experimental cannabidiol and gel (experimental group) and potassium nitrate gel (control group) can change sensitivity related to tooth whitening with hydrogen peroxide 35%. So it is necessary measure this pain. The volunteers will mark on the scale (VAS) the level (1-10) of sensitivity immediately after the intervention, and for a period of 21 days of treatment.
1 secondary outcome
Change in Color of Teeth Bleached by spectrophotometer (VITA Easyshade)(quantitative method: (ΔE00)
Time frame: There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.
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 18 Jun 2025.
- Background: PubMed 40253312Sano IS, de Almeida AS, Xavier GMB, Paes YFO, Silva CM, de Freitas MCC, da Costa RS, Araujo JLN. Synthesis of an experimental gel containing cannabidiol oil and evaluation of effects on bleached bovine enamel. Odontology. 2026 Jan;114(1):108-120. doi: 10.1007/s10266-025-01105-5. Epub 2025 Apr 19.
- Individual participant dataSharing planned: No. Brazilian legislation (LGPD), 13.709/2018
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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.
Jesuína L Nogueira Araújo, PHD principal investigator
Federal University of Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Potassium nitrate and sodium fluoride, Cannabidiol (CBD) Gel and Natrosol 4% Gel in people with Dentin Sensitivity, 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 2 inclusion and 11 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 18 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jesuína L Nogueira Araújo, PHD (5591991442849, jesuinalamartine@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening (time frame: immediately after the intervention, and for a period of 21 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07027566, which also lists 1 linked publication.
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 18 Jun 2025.