NCT06971783

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universidade Federal do Para · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2025-05-14
• Last updated: 2025-05-21

Locations

1 site across 1 country: Brazil