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NOT YET RECRUITING
NCT06417580
PHASE2

Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity

Sponsor: Jesuína Lamartine Nogueira Araújo

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of a gel formulation based on 10% of pregabalin in the treatment of HD and on the participants' quality of life. The sample calculation will be based on previous work. After selecting participants, the participants will be randomly assigned to the following groups: placebo control group (CG), potassium nitrate gel group (GNK) and pregabalin gel group (GPG). A questionnaire (QEDH-15) to assess the impact of desensitizing treatment on oral health-related quality of life (OHRQoL) will be applied at baseline (T0) and in the last sensitivity record (T6). Pain will be assessed using a visual analogue scale after evaporative stimulation with an air jet and tactile stimulation with an exploratory probe. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between them. Sensitivity recording will be performed at T0 (baseline), T1 (after the first session), T2 (after the second session), T3 (after the third session), T4 (7 days after the last session), T5 (one month after the last session) and T6 (3 months after the last session). Data will be collected and subjected to statistical analysis for parametric data (ANOVA followed by Student-Newman-Keuls) or non-parametric data (Friedman's ANOVA followed by Tukey). To analyze the impact on quality of life, the Friedman test will be used.

Official title: Effect of Experimental Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity: a Randomized, Double-blind, Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-05-28

Completion Date

2024-09-28

Last Updated

2024-05-17

Healthy Volunteers

Yes

Interventions

OTHER

Placebo Treatment

Desensitizing protocol with none active ingredient to evaluate the control of cervical dentin hypersensitivity

OTHER

Nitrate Potassium Treatment

Desensitizing protocol with potassium nitrate gel to analyze and compare with other groups the effects of controlling cervical dentin hypersensitivity

OTHER

Pregabalin Treatment

Desensitizing protocol with experimental 10% pregabalin gel to evaluate the control of cervical dentin hypersensitivity