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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Dentin Sensitivity; Dentin Desensitizing Agents
• Intervention / Treatment: Other: Placebo gel; Other: KF2 (Potassium nitrate gel); Other: experimental Copaiba gel

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belém, Pará, Brazil
      • Universidade Federal do Pará

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo gel; the group will receive the application of gel without active ingredient	Other: Placebo gel; will receive the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
Active Comparator: KF2 (Potassium nitrate gel); the group will receive the application of gel containing potassium nitrate	Other: KF2 (Potassium nitrate gel); will receive application of potassium nitrate gel on hypersensitive dental surfaces, in an active way, for 10 minutes.
Experimental: Copaiba gel; the group will receive the application of gel containing copaiba	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity assessment	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.	30 days

Collaborators and Investigators

• Sponsor: Universidade Federal do Para
• Investigators: Principal Investigator: Cecy M Silva, Doctor, Universidade Federal do Pará

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 6.787.218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No