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Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
In-office dental bleaching
Low Level Laser Therapy
5% potassium nitrate / 2% sodium fluoride gel
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 - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Absence of active carious lesions;
  • Never undergone bleaching therapy;
  • Good oral hygiene;
  • Do not present hypersensitivity;
  • Do not smoke;
  • Not being pregnant;
  • Presence of at least 28 teeth in oral cavity.

Exclusion Criteria:

  • Presence of periodontal disease;
  • Presence of cracks or fractures;
  • Presence of restorations and prostheses;
  • Presence of gastroesophageal dysfunction;
  • Patients with severe internal dental dimming;
  • Presence of periodontal disease;
  • Presence of dentin exposure in anterior and/or posterior teeth.

Sites / Locations

  • Brennda Lucy Freitas de Paula

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

G1- Negative Control

G2- LASER (Positive Control)

G3- KNO3 (Positive Control)

G4- KNO3 + LASER

Arm Description

Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).

Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.

Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).

Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.

Outcomes

Primary Outcome Measures

Change in Stimulated pain intensity in different assessment times (P15)
The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).

Secondary Outcome Measures

Non-stimulated pain intensity measure, (P21)
Self reported non-stimulated 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

Full Information

First Posted
January 16, 2018
Last Updated
February 13, 2018
Sponsor
Universidade Federal do Para
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT03434782
Brief Title
Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth
Official Title
Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
November 24, 2017 (Actual)
Study Completion Date
January 15, 2018 (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
To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.
Detailed Description
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.

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
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1- Negative Control
Arm Type
Experimental
Arm Description
Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
Arm Title
G2- LASER (Positive Control)
Arm Type
Experimental
Arm Description
Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.
Arm Title
G3- KNO3 (Positive Control)
Arm Type
Experimental
Arm Description
Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
Arm Title
G4- KNO3 + LASER
Arm Type
Experimental
Arm Description
Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.
Intervention Type
Drug
Intervention Name(s)
In-office dental bleaching
Other Intervention Name(s)
35% hydrogen peroxide
Intervention Description
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Intervention Type
Drug
Intervention Name(s)
Low Level Laser Therapy
Other Intervention Name(s)
LLLT
Intervention Description
It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.
Intervention Type
Drug
Intervention Name(s)
5% potassium nitrate / 2% sodium fluoride gel
Other Intervention Name(s)
desensitizing therapy
Intervention Description
5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol.
Primary Outcome Measure Information:
Title
Change in Stimulated pain intensity in different assessment times (P15)
Description
The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).
Time Frame
15 days, with assessments in the 1st, 8th and 15th day of the treatment
Secondary Outcome Measure Information:
Title
Non-stimulated pain intensity measure, (P21)
Description
Self reported non-stimulated 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
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Absence of active carious lesions; Never undergone bleaching therapy; Good oral hygiene; Do not present hypersensitivity; Do not smoke; Not being pregnant; Presence of at least 28 teeth in oral cavity. Exclusion Criteria: Presence of periodontal disease; Presence of cracks or fractures; Presence of restorations and prostheses; Presence of gastroesophageal dysfunction; Patients with severe internal dental dimming; Presence of periodontal disease; Presence of dentin exposure in anterior and/or posterior teeth.
Facility Information:
Facility Name
Brennda Lucy Freitas de Paula
City
Belem
State/Province
Para
ZIP/Postal Code
66055-280
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21488723
Citation
Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
Results Reference
background
PubMed Identifier
26964798
Citation
Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf
Available IPD/Information Identifier
60622416.1.0000.0018

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Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth

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