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Not yet recruitingNCT07027566Updated Jun 18, 2025

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

A Phase 1 interventional study of Potassium nitrate and sodium fluoride and Cannabidiol (CBD) Gel in Dentin Sensitivity, sponsored by Universidade Federal do Para. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Universidade Federal do Para · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Dentin Sensitivity

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Keywords

  • Tooth Bleaching
  • Cannabidiol
  • Dentin Sensitivity
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 75 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Universidade Federal do Para is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have at least 28 teeth in the cavity
  • Good oral and general health

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (estimated)

Study arms

  • Placebo comparator
    Placebo group

    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).

    Drug: Natrosol 4% Gel

  • Active comparator
    Control group

    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

    Drug: Potassium nitrate and sodium fluoride

  • Experimental
    Experimental group

    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).

    Drug: Cannabidiol (CBD) Gel

Interventions

  • DrugPotassium nitrate and sodium fluoride

    Drug pages: Potassium nitrate · Sodium Fluoride

    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

    Also known as: GC

  • Cannabidiol gel for teeth ( 2% cannabidiol oil) before bleaching with hydrogen peroxide

    Also known as: GCBD

  • DrugNatrosol 4% Gel

    placebo gel (natrosol-based gel 4%) for topical application to teeth before bleaching with hydrogen peroxide.

    Also known as: GP

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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).

    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.

07

Study locations

1 site
08

References and documents

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. 2025 Apr 19. doi: 10.1007/s10266-025-01105-5. Online ahead of print. PubMed 40253312 ↗

Individual participant data

Plan to share: No — Brazilian legislation (LGPD), 13.709/2018

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07027566
Lead sponsor
Universidade Federal do Para
Responsible party
Jesuína Lamartine Nogueira Araújo (Principal Investigator: Clinical Professor, Universidade Federal do Para) — Principal investigator
First posted
Jun 18, 2025
Start date
Jul 25, 2025 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 18, 2025

Study contacts

Jesuína L Nogueira Araújo, PHD
Contact
jesuinalamartine@hotmail.com
5591991442849
Marina L Wanderley, Msc
Contact
marina_lw@hotmail.com
5591992240588
Jesuína L Nogueira Araújo, PHD
principal investigator · Federal University of Pará

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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