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NCT Number: NCT07027566

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

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.

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Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Federal University of Pará School of Dentistry

Belém, Pará, 66075-110, Brazil

Location contact

Cecy M Silva, PHD

SUB_INVESTIGATOR

Sandro C Loretto, PHD

CONTACT

[email protected]

55 91 8122-3477

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Potassium nitrate and sodium fluoride

Drug

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

Other names: GC

Cannabidiol (CBD) Gel

Drug

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

Other names: GCBD

Natrosol 4% Gel

Drug

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

Other names: GP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jesuína L Nogueira Araújo, PHD

CONTACT

[email protected]

5591991442849

Marina L Wanderley, Msc

CONTACT

[email protected]

5591992240588

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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