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Effect of Andiroba on Control of Post-whitening Tooth Sensitivity

U

Universidade Federal do Para

Status

Completed

Conditions

Dentin Desensitizing Agents
Tooth Bleaching
Pain

Treatments

Other: AG (experimental Andiroba Gel)
Other: PG (Placebo Gel)
Other: KF2G (Potassium nitrate gel)

Study type

Interventional

Funder types

Other

Identifiers

NCT06614764
81021724.2.0000.0018

Details and patient eligibility

About

This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).

Full description

All groups will undergo in-office whitening treatment, carried out in 3 sessions with a 7-day interval, according to the steps described below:

Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 15 minutes each, totaling 45 minutes; Final removal of the whitening gel and gingival barrier, followed by rinsing with water.

The application of the desensitizing agent or its placebo will follow this sequence:

Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.

Enrollment

75 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No 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

Single Blind

75 participants in 3 patient groups, including a placebo group

PG- Placebo gel
Placebo Comparator group
Description:
The PG group received the application of placebo gel for post tooth bleaching sensitivity.
Treatment:
Other: PG (Placebo Gel)
GKF2- Potassium nitrate
Active Comparator group
Description:
The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.
Treatment:
Other: KF2G (Potassium nitrate gel)
AG- Andiroba Gel
Experimental group
Description:
The AG group received the application of experimental gel of andiroba (Carapa guianensis) for post tooth bleaching sensitivity.
Treatment:
Other: AG (experimental Andiroba Gel)

Trial contacts and locations

1

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Central trial contact

Cecy M Silva, doctor

Data sourced from clinicaltrials.gov

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