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

NCT ID: NCT04356911

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-11-15

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.

Detailed Description

The objective of this double-blind, randomized, controlled clinical study was to evaluate the effect of 10% strontium chloride associated with photobiomodulation (FBM) on teeth exposed to 35% hydrogen peroxide during 3 weeks of whitening treatment. Methods: 50 volunteers were evaluated by the split mouth model, where the hemiarchy patients were randomized and subsequently allocated to one of the experimental groups: PLACEBO (negative control) - group with no desensitizing treatment, only bleached; FBM (positive control) - group treated with placebo gel and application of the LLLT (Low Level Laser Therapy); ESTRÔNCIO (positive control) - group treated with 10% strontium chloride and simulation of LLLT application (without light emission); and FBM + ESTRÔNCIO - group treated with LLLT + 10% strontium chloride.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PLACEBO (Negative Control)

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).

Group Type: PLACEBO_COMPARATOR

PLACEBO (Negative Control)

Intervention Type: 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.

FBM

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

Group Type: EXPERIMENTAL

FBM

Intervention Type: 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.

ESTRÔNCIO

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).

Group Type: EXPERIMENTAL

ESTRÔNCIO

Intervention Type: 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.

FBM+ESTRÔNCIO

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

Group Type: EXPERIMENTAL

FBM+ESTRÔNCIO

Intervention Type: 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.

Interventions

PLACEBO (Negative Control)

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.

Intervention Type: OTHER

FBM

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.

Intervention Type: OTHER

ESTRÔNCIO

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.

Intervention Type: OTHER

FBM+ESTRÔNCIO

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 31 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

clinical professor

Locations

Para's Federal University

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-007

Identifier Type: -

Identifier Source: org_study_id