The Effect of an Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity

NCT ID: NCT06066671

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-05-07

Brief Summary

This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into 3 different groups - GC (placebo); GN (potassium nitrate and sodium fluoride); GCO (copaiba oil resin). The dental elements of the GCO received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GC and GN groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).

Conditions

Tooth Bleaching Pain

Study Design

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

Study Groups

GCO (Experimental copaiba oil resin gel)

The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity

Group Type: EXPERIMENTAL

GCO (Experimental copaiba oil resin gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.

GN (Potassiun nitrate and sodium fluoride gel)

The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity

Group Type: ACTIVE_COMPARATOR

GCO (Experimental copaiba oil resin gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.

GC

The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity

Group Type: PLACEBO_COMPARATOR

GCO (Experimental copaiba oil resin gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.

Interventions

GCO (Experimental copaiba oil resin gel)

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• good oral hygiene
• absence of active caries lesions
• never undergone bleaching therapy
• not present dental hypersensitivity
• don't be a smoker
• don´t be pregnant
• present at least 28 teeth in the oral cavity

Exclusion Criteria

• volunteers undergoing orthodontic treatment,
• presence of periodontal disease
• dental cracks or fractures
• restorations and prostheses on anterior teeth
• extensive molar restorations
• gastroesophageal disorders
• severe internal dental darkening
• presence of dentinal exposure in anterior and / or posterior teeth.

• 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 Federal Univeersity of Pará

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Para

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara016

Identifier Type: -

Identifier Source: org_study_id