Clinical trial NCT06614764: Effect of Andiroba on Control of Post-whitening Tooth Sensitivity
Official title: Effect of Andiroba on Control of Post-whitening Tooth Sensitivity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Pain
Dentin Desensitizing Agents
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don\&#39;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.

Primary outcomes:
measure: Post-whitening sensitivity assessment
timeFrame: Period: 21 days
Secondary outcomes:
measure: Color evaluation
timeFrame: Baseline (Ti) and one week after the 3rd whitening session (Tf).
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: UFPA
state: Pará
Study officials:
affiliation: Universidade federal do Pará
name: Cecy M Silva, doctor
role: PRINCIPAL_INVESTIGATOR
References: