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

NCT ID: NCT06971783

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2025-03-20

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.

Detailed Description

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.

Conditions

Dentin Desensitizers; Non-carious Cervical Lesions; Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CT group: negative control group

the group will receive the application of gel without active ingredient

Group Type: PLACEBO_COMPARATOR

CT- control group

Intervention Type: OTHER

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

NP Group - Potassium nitrate associated with 2% Fluoride

the group will receive the application of gel containing potassium nitrate

Group Type: ACTIVE_COMPARATOR

NP- Potassium nitrate gel

Intervention Type: 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.

Group AO - Acmella Oleracea extract gel

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

Group Type: EXPERIMENTAL

AO - Acmella Oleracea Extract Gel

Intervention Type: 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 Group - Acmella Oleracea extract gel associated with Fluoride.

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

Group Type: EXPERIMENTAL

AF - Gel of Acmella Oleracea extract associated with Fluoride.

Intervention Type: 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.

Interventions

CT- control group

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Professor of the Graduate Program in Dentistry at the Federal University of Pará

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva

Role: PRINCIPAL_INVESTIGATOR

universidade federal do pará

Locations

Universidade Federal Do Para

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

7.513.177

Identifier Type: -

Identifier Source: org_study_id