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

Last updated: May 16, 2025
Sponsor: Universidade Federal do Para
Overall Status: Completed

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

experimental Copaiba gel

KF2 (Potassium nitrate gel)

Placebo gel

Clinical Study ID

NCT06872749
6.787.218
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • hypersensitive areas on the vestibular surface of the teeth with exposed cervicaldentin up to 1 mm deep and/or class I gingival recession according to the Millerclassification;

  • 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

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 theassessment of hypersensitivity

Study Design

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: experimental Copaiba gel
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
March 10, 2025

Study 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.

Connect with a study center

  • Universidade Federal Do Para

    Belém, Pará
    Brazil

    Site Not Available

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