Clinical trial NCT06971783: Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity
Official title: Effect of an Experimental Gel Based on Acmella Oleracea Extract Associated or Not With Fluoride on Dentin Hypersensitivity: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Desensitizers
Non-carious Cervical Lesions
Dentin Hypersensitivity
Keywords: Acmella oleracea
Spilanthol
Dentin hypersensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: sensitivity assessment
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade Federal Do Para
state: Pará
Study officials:
affiliation: universidade federal do pará
name: Cecy M Silva
role: PRINCIPAL_INVESTIGATOR
References: