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Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser
nano-hydroxyapatite
Laser + nano-hydroxyapatite
PLACEBO
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 focused on measuring nano-hydroxyapatite, Laser, desensitizing

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

- The presence of at least one hypersensitive tooth;

Exclusion criteria:

  • patients with systemic diseases;
  • patients with pulpitis;
  • patients with carious lesions;
  • patients with defective restorations;
  • patients with cleft enamel;
  • patients with active periodontal disease;
  • patients with analgesic medication;
  • patients with pregnant or lactating women
  • patients who have received professional desensitizing treatment in the last three months.

Sites / Locations

  • Federal University of Pará

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

GPLACEBO

Gn-HAP

GLASER

GLASERnHAP

Arm Description

In this group, a toothpaste without addition of fluoride or any other desensitizing agent (Natural, Contente®, Uberlândia, MG, Brazil) was applied to hypersensitive dentine. The GPLACEBO volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds on each tooth.

In this group a desensitizing gel containing 20% of nano-hydroxyapatite, 9000 ppm of sodium fluoride and 5% of potassium nitrate (Desensibilize Nano P, FGM®, Joinville, SC, Brazil) was applied to the hypersensitive dentin. The GnHAP volunteers will be submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications.

In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil) was applied in hypersensitive dentine. GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours.

In this group the laser + nano-hydroxyapatite was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, São Carlos, SP, Brazil) and a gel containing 20% nanohydroxyapatite, 9000 ppm sodium fluoride 5% potassium nitrate (Desensibilize Nano P, FGM®, Joinville, SC, Brazil) in hypersensitive dentin. GLASERnHAP first named a laser application and then an application of nanohydroxyapatite according to the manufacturer's recommendations.

Outcomes

Primary Outcome Measures

Pain intensity change
Self reported intensity dentin sensitivity before and after desensitizing treatment. Each item is scored 1-10 (0-no pain and 10- pain as bad as can be)

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
August 16, 2018
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT03637426
Brief Title
Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity
Official Title
Effect of Nano-hydroxyapatite and Low-level Laser Therapy on Dentin Hypersensitivity Control: Clinical, Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
August 3, 2018 (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
Yes

5. Study Description

Brief Summary
The aim of this study was to evaluate the effect of nanohydroxyapatite associated with low potency laser therapy in eliminating or reducing dentin hypersensitivity in a randomized placebo-controlled clinical trial. Volunteers 18 to 50 years old with hypersensitive teeth were randomized into 4 groups: GPLACEBO - positioning of the laser tip without light emission + placebo dentifrice; GnHAP - positioning of the laser tip without light emission + nano-hydroxyapatite; GLASER - laser tip positioning with light emission + placebo substance; GLASERnHAP - positioning by laser beam with light emission + nano-hydroxyapatite.
Detailed Description
GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours. GLASERnHAP first received laser application and then the application of nanohydroxyapatite according to the manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated with a tester (MMOptics Ltda®, São Carlos, SP, Brazil). The GnHAP volunteers were submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications. GPLACEBO followed the same protocol used in Gn-HAP. In addition to the desensitization treatment, all GnHAP and GPLACEBO volunteers received the positioning of the laser tip to mimic the light emission produced in GLASER and GLASERnHAP. The noise emitted by the laser device during mimicry was simulated through the sound reproduction of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, Cupertino, California, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
nano-hydroxyapatite, Laser, desensitizing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Volunteers 18 to 50 years old with hypersensitive teeth were randomly assigned to 4 groups: GPLACEBO - positioning of the laser tip without light emission + placeo substance; GnHAP - positioning of the laser tip without light emission + nano-hydroxyapatite; GLASER - positioning of the laser tip with light emission + plcebo substance; GLASERnHAP - positioning by laser beam with light emission + nano-hydroxyapatite.
Masking
ParticipantInvestigator
Masking Description
For this double-blind study, the evaluator and the patient were blinded. Only one evaluator assessed pain sensitivity, who did not participate in the randomization process, and also did not know in which group the patient was. The volunteers evaluated in the experiment also were not aware of the treatment to which they were submitted. Both the Nano-P desensitizer and the placebo toothpaste have the same coloration and similar visual appearance. The desensitizers were placed in equal containers so that patients were not identified as to the application of the product.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GPLACEBO
Arm Type
Placebo Comparator
Arm Description
In this group, a toothpaste without addition of fluoride or any other desensitizing agent (Natural, Contente®, Uberlândia, MG, Brazil) was applied to hypersensitive dentine. The GPLACEBO volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds on each tooth.
Arm Title
Gn-HAP
Arm Type
Experimental
Arm Description
In this group a desensitizing gel containing 20% of nano-hydroxyapatite, 9000 ppm of sodium fluoride and 5% of potassium nitrate (Desensibilize Nano P, FGM®, Joinville, SC, Brazil) was applied to the hypersensitive dentin. The GnHAP volunteers will be submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications.
Arm Title
GLASER
Arm Type
Experimental
Arm Description
In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil) was applied in hypersensitive dentine. GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours.
Arm Title
GLASERnHAP
Arm Type
Experimental
Arm Description
In this group the laser + nano-hydroxyapatite was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, São Carlos, SP, Brazil) and a gel containing 20% nanohydroxyapatite, 9000 ppm sodium fluoride 5% potassium nitrate (Desensibilize Nano P, FGM®, Joinville, SC, Brazil) in hypersensitive dentin. GLASERnHAP first named a laser application and then an application of nanohydroxyapatite according to the manufacturer's recommendations.
Intervention Type
Other
Intervention Name(s)
Laser
Other Intervention Name(s)
Low level laser therapy
Intervention Description
GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours.
Intervention Type
Other
Intervention Name(s)
nano-hydroxyapatite
Other Intervention Name(s)
dentin desensitization agent based on nano-hydroxyapatite
Intervention Description
The GnHAP volunteers were submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications
Intervention Type
Other
Intervention Name(s)
Laser + nano-hydroxyapatite
Intervention Description
GLASERnHAP first received laser application and subsequently the application of nanohydroxyapatite according to the manufacturer's recommendations.
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
In this group, a toothpaste without addition of fluoride or any other desensitizing agent (Natural, Contente®, Uberlândia, MG, Brazil) was applied to hypersensitive dentine. The GPLACEBO volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid 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 low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds on each tooth.
Primary Outcome Measure Information:
Title
Pain intensity change
Description
Self reported intensity dentin sensitivity before and after desensitizing treatment. Each item is scored 1-10 (0-no pain and 10- pain as bad as can be)
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: - The presence of at least one hypersensitive tooth; Exclusion criteria: patients with systemic diseases; patients with pulpitis; patients with carious lesions; patients with defective restorations; patients with cleft enamel; patients with active periodontal disease; patients with analgesic medication; patients with pregnant or lactating women patients who have received professional desensitizing treatment in the last three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva, pHD
Organizational Affiliation
Federal University of Para
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Pará
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

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