NCT06872749

Effect of an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity

Effect on an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity: a Randomized Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Universidade Federal do Para · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This randomized, single-blind, placebo-controlled clinical trial aims to clinically evaluate the effect of an experimental gel containing copaiba oleo-resin in the control of dentin hypersensitivity (DH) in non-carious cervical lesions (NCCL). Seventy-five hypersensitive teeth will be selected into three groups (N=25) and approved in three treatment sessions. The groups will be: GROUP P= water-soluble placebo gel without active ingredient; GROUP KF2: Potassium nitrate 5% + Sodium fluoride 2%; GROUP GC: Gel containing copaiba oleo-resin. A visual analogue scale (VAS) will be used to compare the DH after tactile stimulation with an exploratory probe and evaporative stimulation with air jets. The DH assessments will be performed at four times: baseline, after 1 week, 15 days and 30 days after the beginning of treatment.

Detailed description

The sequence of application of the gels, whether active or placebo, will be as follows: A professional prophylaxis will be performed using a rubber cup on the dental elements. The corresponding gel for each group will be applied with the aid of a micro-applicator and will remain undisturbed on the surface for 10 minutes. After the gel application time has elapsed, and while it is still on the teeth, the product will be rubbed with a micro-applicator using circular and intermittent movements. Subsequently, the gel will be removed with cotton and abundant water.

Conditions

• Pain
• Dentin Sensitivity
• Dentin Desensitizing Agents

Interventions

Type	Name	Description
OTHER	Placebo gel	will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
OTHER	KF2 (Potassium nitrate gel)	will receive application of potassium nitrate gel on hypersensitive dental surfaces, in an active way, for 10 minutes.
OTHER	experimental Copaiba gel	will receive the application of the experimental desensitizing gel on the vestibular surfaces of the hypersensitive teeth in an active manner, for 10 minutes.

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2025-03-12
• Last updated: 2025-05-20

Locations

1 site across 1 country: Brazil