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

NCT ID: NCT06872749

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-03-10

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.

Conditions

Pain; Dentin Sensitivity; Dentin Desensitizing Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo gel

the group will receive the application of gel without active ingredient

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: 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)

the group will receive the application of gel containing potassium nitrate

Group Type: ACTIVE_COMPARATOR

KF2 (Potassium nitrate gel)

Intervention Type: OTHER

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

Copaiba gel

the group will receive the application of gel containing copaiba

Group Type: EXPERIMENTAL

experimental Copaiba gel

Intervention Type: 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.

Interventions

Placebo gel

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

Intervention Type: OTHER

KF2 (Potassium nitrate gel)

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Professor of the Graduate Program in Dentistry at the Federal University of Pará

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva, Doctor

Role: PRINCIPAL_INVESTIGATOR

universidade federal do pará

Locations

Universidade Federal Do Para

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

6.787.218

Identifier Type: -

Identifier Source: org_study_id