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

U

Universidade Federal do Para

Status

Completed

Conditions

Tooth Bleaching Pain

Treatments

Other: GCO (Experimental copaiba oil resin gel)

Study type

Interventional

Funder types

Other

Identifiers

NCT06066671
UFPara016

Details and patient eligibility

About

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).

Enrollment

75 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups, including a placebo group

GCO (Experimental copaiba oil resin gel)
Experimental group
Description:
The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity
Treatment:
Other: GCO (Experimental copaiba oil resin gel)
GN (Potassiun nitrate and sodium fluoride gel)
Active Comparator group
Description:
The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity
Treatment:
Other: GCO (Experimental copaiba oil resin gel)
GC
Placebo Comparator group
Description:
The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity
Treatment:
Other: GCO (Experimental copaiba oil resin gel)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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