Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

NCT07027566 | Not Yet Recruiting Phase 1

• 1 other identifier: PPGOUFPAFO
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Tooth Bleaching; Cannabidiol; Dentin Sensitivity

Outcome Measures

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.

  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)

  There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.

Study Arms (3)

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).

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

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).

Drug: Cannabidiol (CBD) Gel

Interventions

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

Also known as: GC

Control group

Cannabidiol (CBD) Gel DRUG

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

Also known as: GCBD

Experimental group

Natrosol 4% Gel DRUG

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

Also known as: GP

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Federal University of Pará School of Dentistry

Belém, Pará, 66075-110, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40253312 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate; Sodium Fluoride; Cannabidiol; Gels

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jesuína L Nogueira Araújo, PHD

  Federal University of Pará

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesuína L Nogueira Araújo, PHD

CONTACT

5591991442849; jesuinalamartine@hotmail.com

Marina L Wanderley, Msc

CONTACT

5591992240588; marina_lw@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Clinical Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 18, 2025
• Study Start: July 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)