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Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity

NCT06971783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-21

No results posted yet for this study

Summary

This randomized, single-blind, placebo-controlled clinical trial aims to evaluate the effect of an experimental gel based on Acmella oleracea (jambú) extract, associated or not with fluoride, in reducing dentin hypersensitivity (DH) in non-carious cervical lesions. The volunteers were randomized into 4 groups according to the treatments applied: CT (control), NP (potassium nitrate), AO (Acmella oleracea) and AF (Acmella oleracea associated with fluoride). Prophylaxis with pumice stone and water was performed on the previously selected teeth and, subsequently, the gels were applied to the cervical region with a microbrush, rubbed for 10 seconds, and remained on the tooth surface for 10 minutes. Three gel application sessions were performed, with 1-week interval between them. The DH evaluation was performed at four time points: baseline (before the first session), T1 (before the second session), T2 (before the third session) and T3, one week after the final application of the products.

Conditions

  • Dentin Desensitizers
  • Non-carious Cervical Lesions
  • Dentin Hypersensitivity

Interventions

OTHER

CT- control group

will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.

OTHER

NP- Potassium nitrate gel

The gels will be applied to the sensitive lesions according to the experimental group and will be rubbed for 20 seconds using a microbrush, remaining on the lesions for 10 minutes.

OTHER

AO - Acmella Oleracea Extract Gel

The Acmella oleracea gel will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes.

OTHER

AF - Gel of Acmella Oleracea extract associated with Fluoride.

The Acmella oleracea gel associated with fluoride will be applied to sensitive lesions and rubbed for 20 seconds with the aid of a microbrush, remaining on the lesions for 10 minutes.

Sponsors & Collaborators

  • Universidade Federal do Para

    lead OTHER

Principal Investigators

  • Cecy M Silva · universidade federal do pará

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2025-03-20
Completion
2025-03-20

Countries

  • Brazil

Study Locations

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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 NCT06971783 on ClinicalTrials.gov