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NCT Number: NCT06971783

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

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.

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Key information

Conditions

Dentin Desensitizers Dentin Hypersensitivity Dentin Sensitivity Non-carious Cervical Lesions Stomatognathic Diseases Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Do Para

Belém, Pará, Brazil

About this study

Initially, all volunteers will undergo prophylaxis with pumice and water and will receive an oral hygiene kit containing a soft-bristled toothbrush, dental floss, and their assigned toothpaste, along with oral hygiene instructions. Relative isolation with cotton rolls will be performed in the region of the sensitive lesions, followed by the application of the gel corresponding to the participant's group (CT, NP, AO, AF). All gels will be applied in the same manner, using a microbrush applicator. After being rubbed for 20 seconds on each tooth, the gel will remain on the tooth surface for 10 minutes. At the end of this period, the gel will be removed using gauze and thoroughly rinsed. Three clinical sessions will be conducted, with one-week intervals between them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of non-carious cervical lesions with sensitivity and up to 2 mm in depth
  • Miller Class I gingival recession
  • Lesions located on the buccal surface of the teeth
  • Score ≥ 4 on the Visual Analog Scale (VAS) after tactile and evaporative stimuli
  • Healthy periodontal condition
  • No other conditions that could explain dentin hypersensitivity
  • Good general physical health
  • No eating disorders or high-acid diets
  • Occlusal stability

Exclusion criteria

  • Presence of restorations in the hypersensitive areas
  • Presence of dental caries, pulpitis, or periodontal pockets
  • Enamel cracks
  • Systemic diseases
  • Continuous use of antibiotics, anti-inflammatory drugs, analgesics, or corticosteroids
  • Professional desensitizing treatment received within the three months prior to study recruitment
  • Pregnancy or breastfeeding Ongoing orthodontic treatment
  • Dental prostheses that may interfere with the assessment of hypersensitivity

Treatment and study plan

CT- control group

Other

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

NP- Potassium nitrate gel

Other

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.

AO - Acmella Oleracea Extract Gel

Other

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.

AF - Gel of Acmella Oleracea extract associated with Fluoride.

Other

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.

Primary outcomes

  1. sensitivity assessment

    Time frame: 30 days

    Dentin hypersensitivity (DH) will be assessed at four time points: baseline (immediately before the first session), T1 (immediately before the second session), T2 (immediately before the third session), and T3 (one week after the final application of the products). DH will be evaluated using the Visual Analog Scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at each end, where 0 indicates no sensitivity and 10 indicates severe dental sensitivity. Patients will be instructed to draw a vertical line along the horizontal scale to indicate the intensity of their dental sensitivity on the day of assessment.The distance from the zero end to the patient's mark will be measured using a millimeter ruler. These data will be recorded and tabulated for subsequent analysis.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity: a Randomized Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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