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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06872749
Enrollment
75
Registered
2025-03-12
Start date
2024-09-20
Completion date
2025-03-10
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Desensitizing Agents, Dentin Sensitivity, Pain

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.

Interventions

OTHERPlacebo gel

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

OTHERKF2 (Potassium nitrate gel)

will receive application of potassium nitrate gel on hypersensitive dental surfaces, in an active way, for 10 minutes.

OTHERexperimental 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.

Sponsors

Universidade Federal do Para
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
sensitivity assessment30 daysEvaluation of hypersensitivity in teeth with non-carious cervical lesions. Patients will be instructed to complete a form to record tooth sensitivity before the application of the gels. An evaluation will be performed at baseline, 7 days, 15 days and 30 days, based on their individual perception of pain. The evaluation form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with points of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the intensity level of the patient's back.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026