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

NCT06971783 | Completed

• 1 other identifier: 7.513.177
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acmella oleracea; Spilanthol; Dentin hypersensitivity

Outcome Measures

Primary Outcomes (1)

• sensitivity assessment

  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.

  30 days

Study Arms (4)

CT group: negative control group

PLACEBO COMPARATOR

the group will receive the application of gel without active ingredient

Other: CT- control group

NP Group - Potassium nitrate associated with 2% Fluoride

ACTIVE COMPARATOR

the group will receive the application of gel containing potassium nitrate

Other: NP- Potassium nitrate gel

Group AO - Acmella Oleracea extract gel

EXPERIMENTAL

the group will receive the application of gel containing Acmella Oleracea Extract Gel

Other: AO - Acmella Oleracea Extract Gel

AF Group - Acmella Oleracea extract gel associated with Fluoride.

EXPERIMENTAL

the group will receive the application of gel containing Acmella Oleracea Extract Gel associated with fluoride

Other: AF - Gel of Acmella Oleracea extract associated with Fluoride.

Interventions

CT- control group OTHER

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

CT group: negative control group

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.

NP Group - Potassium nitrate associated with 2% Fluoride

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.

Group AO - Acmella Oleracea extract gel

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.

AF Group - Acmella Oleracea extract gel associated with Fluoride.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Universidade Federal Do Para

Belém, Pará, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Cecy M Silva

  universidade federal do pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Graduate Program in Dentistry at the Federal University of Pará

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: August 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)