Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

ConditionDentin Sensitivity

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-40

SponsorUniversidade Federal do Para

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Participants must have at least 28 teeth in the cavity

Good oral and general health

Disqualifiers

active caries or periodontal disease

visible cracks in front teeth upper or lower

with evident malocclusion

restorations and prosthetics in teeth anterior teeth

Trial design

Design model

Parallel

Treatments tested in this trial

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
Cannabidiol (CBD) Gel
Drug
Cannabidiol gel for teeth ( 2% cannabidiol oil) before bleaching with hydrogen peroxide
Natrosol 4% Gel
Drug
placebo gel (natrosol-based gel 4%) for topical application to teeth before bleaching with hydrogen peroxide.

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Placebo groupPlacebo comparator 1 intervention

Group B: Control groupActive comparator 1 intervention

Group C: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal do Para

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: