Clinical trial NCT07027566: Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity
Official title: Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Dentin Sensitivity
Keywords: Tooth Bleaching
Cannabidiol
Dentin Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening
timeFrame: immediately after the intervention, and for a period of 21 days of treatment
Secondary outcomes:
measure: Change in Color of Teeth Bleached by spectrophotometer (VITA Easyshade)(quantitative method: (ΔE00)
timeFrame: There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Pará School of Dentistry
state: PA
Study officials:
affiliation: Federal University of Pará
name: Jesuína L Nogueira Araújo, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.