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Completed

NCT Number: NCT06872749

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

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.

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Key information

Conditions

Pain Dentin Desensitizing Agents Dentin Sensitivity Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Do Para

Belém, Pará, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo gel

Other

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

KF2 (Potassium nitrate gel)

Other

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

experimental Copaiba gel

Other

will receive the application of the experimental desensitizing gel on the vestibular surfaces of the hypersensitive teeth in an active manner, for 10 minutes.

Primary outcomes

  1. sensitivity assessment

    Time frame: 30 days

    Evaluation 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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