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Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity
Sponsor: Jesuína Lamartine Nogueira Araújo
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
Conditions
Interventions
Placebo Treatment
Desensitizing protocol with none active ingredient to evaluate the control of cervical dentin hypersensitivity
Nitrate Potassium Treatment
Desensitizing protocol with potassium nitrate gel to analyze and compare with other groups the effects of controlling cervical dentin hypersensitivity
Pregabalin Treatment
Desensitizing protocol with experimental 10% pregabalin gel to evaluate the control of cervical dentin hypersensitivity