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

NCT06872749 | Completed

• 1 other identifier: 6.787.218
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Dentin Sensitivity; Dentin Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo gel

PLACEBO COMPARATOR

the group will receive the application of gel without active ingredient

Other: Placebo gel

KF2 (Potassium nitrate gel)

ACTIVE COMPARATOR

the group will receive the application of gel containing potassium nitrate

Other: KF2 (Potassium nitrate gel)

Copaiba gel

EXPERIMENTAL

the group will receive the application of gel containing copaiba

Other: experimental Copaiba gel

Interventions

Placebo gel OTHER

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

Placebo gel

KF2 (Potassium nitrate gel) OTHER

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

KF2 (Potassium nitrate gel)

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.

Copaiba gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Universidade Federal Do Para

Belém, Pará, Brazil

Location

MeSH Terms

Conditions

Pain; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cecy M Silva, Doctor

  universidade federal do pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Graduate Program in Dentistry at the Federal University of Pará

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: March 12, 2025
• Study Start: September 20, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-03

Locations

BR (1)