Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Low Level Laser Therapy
1.1% Sodium Fluoride
In-office dental bleaching
Sponsored by
About this trial
This is an interventional prevention trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Absence of active carious lesions;
- Good oral hygiene;
- Do not present hypersensitivity;
- Do not smoke;
- Not being pregnant.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
G-FLUOR+LASER
G-FLUOR
Arm Description
The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching
Outcomes
Primary Outcome Measures
Stimulated pain intensity measure (P5)
Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Secondary Outcome Measures
Non-stimulated pain intensity measure, (P28)
Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Recurrence of stimulated pain
Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Full Information
NCT ID
NCT03044171
First Posted
January 30, 2017
Last Updated
March 16, 2017
Sponsor
Universidade Federal do Para
1. Study Identification
Unique Protocol Identification Number
NCT03044171
Brief Title
Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
Official Title
Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
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 prevent dental sensitivity.
Detailed Description
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .
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
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G-FLUOR+LASER
Arm Type
Experimental
Arm Description
The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
Arm Title
G-FLUOR
Arm Type
Experimental
Arm Description
The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Other Intervention Name(s)
LLLT
Intervention Description
Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.
Intervention Type
Drug
Intervention Name(s)
1.1% Sodium Fluoride
Other Intervention Name(s)
Fluoride therapy
Intervention Description
Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.
Intervention Type
Drug
Intervention Name(s)
In-office dental bleaching
Other Intervention Name(s)
35% hydrogen peroxide
Intervention Description
Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.
Primary Outcome Measure Information:
Title
Stimulated pain intensity measure (P5)
Description
Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Non-stimulated pain intensity measure, (P28)
Description
Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Time Frame
28 days
Title
Recurrence of stimulated pain
Description
Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Absence of active carious lesions;
Good oral hygiene;
Do not present hypersensitivity;
Do not smoke;
Not being pregnant.
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.
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
57655916.3.0000.0018
Learn more about this trial
Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
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