Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Natrosol 4% Gel

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Potassium nitrate and sodium fluoride

Intervention Type 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

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).

Group Type EXPERIMENTAL

Cannabidiol (CBD) Gel

Intervention Type DRUG

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

Interventions

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Potassium nitrate and 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

Intervention Type DRUG

Cannabidiol (CBD) Gel

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

Intervention Type DRUG

Natrosol 4% Gel

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

Intervention Type DRUG

Other Intervention Names

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GC GCBD GP

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No