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The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity

U

Universidade Federal do Para

Status

Completed

Conditions

Dentin Desensitizing Agents
Tooth Bleaching
Pain

Treatments

Other: EG (Experimental A. Oleracea extract gel)
Other: GP (Gel placebo)

Study type

Interventional

Funder types

Other

Identifiers

NCT05725850
UFPara-015

Details and patient eligibility

About

This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The dental elements of the GE 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 GP group also received the application of a placebo gel (without active ingredient), 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

50 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • volunteers who were under 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

50 participants in 2 patient groups, including a placebo group

EG (Experimental A. Oleracea extract gel)
Experimental group
Description:
The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.
Treatment:
Other: EG (Experimental A. Oleracea extract gel)
GP (Gel placebo)
Placebo Comparator group
Description:
The GP group received the application of a placebo gel.
Treatment:
Other: GP (Gel placebo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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