search
Back to results

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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PLACEBO (Negative Control)
FBM
ESTRÔNCIO
FBM+ESTRÔNCIO
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 31 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Para's Federal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

PLACEBO (Negative Control)

FBM

ESTRÔNCIO

FBM+ESTRÔNCIO

Arm Description

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).

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

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2020
Last Updated
April 18, 2020
Sponsor
Universidade Federal do Para
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT04356911
Brief Title
The Strontium Chloride Associated With Photobiomodulation in the Control of Post-bleaching Sensitivity
Official Title
The Association of Strontium Chloride With Photobiomodulation in the Control of Tooth Post-bleaching Sensitivity: Clinical Trial, Randomized, Double-blind and Split-mouth.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLACEBO (Negative Control)
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
FBM
Arm Type
Experimental
Arm Description
The group received the application of a placebo gel associated with LLLT after office bleaching.
Arm Title
ESTRÔNCIO
Arm Type
Experimental
Arm Description
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).
Arm Title
FBM+ESTRÔNCIO
Arm Type
Experimental
Arm Description
After whitening in the office, the group received a 10% strontium chloride desensitizer associated with low level light therapy.
Intervention Type
Other
Intervention Name(s)
PLACEBO (Negative Control)
Intervention Description
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
Intervention Name(s)
FBM
Intervention Description
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
Intervention Name(s)
ESTRÔNCIO
Intervention Description
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
Intervention Name(s)
FBM+ESTRÔNCIO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva, PhD
Organizational Affiliation
clinical professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Para's Federal University
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs