The Strontium Chloride Associated With Photobiomodulation in the Control of Post-bleaching Sensitivity

NCT04356911 | Completed

• 1 other identifier: UFPara-007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effects of the association of strontium chloride with photobiomodulation on the dental bleaching process, testing the hypothesis that they may control dental sensitivity post-bleaching teeth.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)

  Self-reported pain intensity was assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation was performed by each patient, according to a modified visual analog scale, as follows: 0- no pain, 1 mild pain, 2 - moderate pain and 3 -severe pain.

  21 days

Study Arms (4)

PLACEBO (Negative Control)

PLACEBO COMPARATOR

The dental elements of this group had no desensitizing treatment. After whitening therapy, a water-soluble placebo gel (KY®, Johnson \& Johnson, SP, Brazil) was applied to dental oral surfaces, then the laser tip was positioned at two points, apical and cervical, without emitting light (placebo), simulating the application of Low Level Laser Therapy (LLLT).

Other: PLACEBO (Negative Control)

FBM

EXPERIMENTAL

The group received the application of a placebo gel associated with LLLT after office bleaching.

Other: FBM

ESTRÔNCIO

EXPERIMENTAL

After whitening in-office bleaching, the group was treated with desensitization to 10% strontium chloride. Subsequently, a laser tip was positioned at two points (apical and cervical), without emitting light (placebo).

Other: ESTRÔNCIO

FBM+ESTRÔNCIO

EXPERIMENTAL

After whitening in the office, the group received a 10% strontium chloride desensitizer associated with low level light therapy.

Other: FBM+ESTRÔNCIO

Interventions

PLACEBO (Negative Control) OTHER

The group received in-office bleaching. A 45-minute application of 35% hydrogen peroxide gel (Whiteness HP, FGM, Joinville, SC) was carried. After whitening therapy, a water-soluble placebo gel (KY®, Johnson \& Johnson, SP, Brazil) was applied to the buccal surfaces of incisors, canines and premolars with the help of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the placebo gel for 20 seconds in each tooth surface. After washing the placebo gel, the laser tip was positioned at two points, apical and cervical, without emitting light (placebo), simulating the application of low-level laser therapy (LLLT). This protocol was performed in 3 sessions, with an interval of seven days between them.

PLACEBO (Negative Control)

FBM OTHER

This group received photobimodulation with low level laser therapy (LLLT) of infrared spectrum with a wavelength of 808 nm in its active environment AsGaAl (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil), at two points: cervical and apical region of the incisors, canines and premolars. 60 J / cm² was applied at each point for 16 seconds. The laser was applied in 3 sessions with a time interval of seven days between them.

FBM

ESTRÔNCIO OTHER

After whitening therapy, a toothpaste with 10% strontium chloride (Sensodyne Original, GSK, London, United Kingdom) was applied to the buccal surfaces of incisors, canines and premolars with the help of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the desensitizer for 20 seconds on each tooth , according to the manufacturer's specifications. The desensitizer therapy was realized in 3 sessions with a time interval of seven days between them.

ESTRÔNCIO

FBM+ESTRÔNCIO OTHER

After whitening therapy, a 10% strontium chloride toothpaste (Sensodyne Original, GSK, London, United Kingdom) was applied to the buccal surfaces of whitened teeth with the help of a Microbrush applicator applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the desensitizer for 20 seconds on each tooth , according to the manufacturer's specifications. After washing the desensitizer, the photobimodulation was realized with Low Level Laser Therapy (LLLT) of infrared spectrum with wavelength of 808 nm in its active environment AsGaAl (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil), in two points: cervical and apical region of the incisors, canines and premolars. 60 J / cm² was applied at each point for 16 seconds. This protocol was performed in 3 sessions, with an interval of seven days between them.

FBM+ESTRÔNCIO

Eligibility Criteria

• Age: 18 Years - 31 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Para's Federal University

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cecy M Silva, PhD

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 22, 2020
• Study Start: August 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

BR (1)