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Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity

NCT06417580 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

  • Dentin Sensitivity

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

Sponsors & Collaborators

  • Jesuína Lamartine Nogueira Araújo

    lead OTHER

Principal Investigators

  • Jesuina L Nogueira Araujo, Doctor · Federal University of Pará

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2024-09-28
Completion
2024-09-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06417580 on ClinicalTrials.gov