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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Other: PLACEBO (Negative Control); Other: ESTRÔNCIO; Other: FBM; Other: FBM+ESTRÔNCIO

• Registration Number: NCT04356911
• Lead Sponsor: Universidade Federal do Para

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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PLACEBO (Negative Control)	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).
ESTRÔNCIO	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).
FBM	FBM	The group received the application of a placebo gel associated with LLLT after office bleaching.
FBM+ESTRÔNCIO	FBM+ESTRÔNCIO	After whitening in the office, the group received a 10% strontium chloride desensitizer associated with low level light therapy.

Primary Outcome Measures

Name	Time	Method
Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)	21 days	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.

Trial Locations

Locations (1)

Para's Federal University; 🇧🇷 Belém, Pará, Brazil