Clinical trial NCT06872749: Effect of an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity
Official title: Effect on an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Dentin Sensitivity
Dentin Desensitizing Agents
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* hypersensitive areas on the vestibular surface of the teeth with exposed cervical dentin up to 1 mm deep and/or class I gingival recession according to the Miller classification;
* individuals who have at least two hypersensitive teeth
* periodontal health,
* good general physical health;
* willingness to participate in the research by providing written informed consent;
* no eating disorders or very acidic diets

Exclusion Criteria:

* presence of restorations;
* presence of dental caries and periodontal pockets;
* ongoing treatment with antibiotics and/or anti-inflammatory and/or analgesic drugs;
* professional desensitizing treatment received three months prior to the study;
* pregnancy or lactation; systemic diseases;
* pulpitis;
* use of orthodontic appliances or 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, Doctor
role: PRINCIPAL_INVESTIGATOR
References: