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Trial record 29 of 32 for:    FLUORIDE ION AND NITRATE ION

Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

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ClinicalTrials.gov Identifier: NCT03637426
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Cecy Martins Silva, Universidade Federal do Para

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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Other: Laser Other: nano-hydroxyapatite Other: Laser + nano-hydroxyapatite Other: PLACEBO Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: Effect of Nano-hydroxyapatite and Low-level Laser Therapy on Dentin Hypersensitivity Control: Clinical, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : August 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Durapatite

Arm Intervention/treatment
Placebo Comparator: GPLACEBO
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.
Other: PLACEBO
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.

Experimental: Gn-HAP
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.
Other: nano-hydroxyapatite
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
Other Name: dentin desensitization agent based on nano-hydroxyapatite

Experimental: GLASER

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.

Other: Laser
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.
Other Name: Low level laser therapy

Experimental: GLASERnHAP
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.
Other: Laser + nano-hydroxyapatite
GLASERnHAP first received laser application and subsequently the application of nanohydroxyapatite according to the manufacturer's recommendations.




Primary Outcome Measures :
  1. Pain intensity change [ Time Frame: up to 2 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637426


Locations
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Brazil
Federal University of Pará
Belém, PA, Brazil, 66075-110
Sponsors and Collaborators
Universidade Federal do Para
Investigators
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Principal Investigator: Cecy M Silva, pHD Federal University of Para

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Responsible Party: Cecy Martins Silva, Clinical Professor, Universidade Federal do Para
ClinicalTrials.gov Identifier: NCT03637426     History of Changes
Other Study ID Numbers: UFPara-004
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cecy Martins Silva, Universidade Federal do Para:
nano-hydroxyapatite
Laser
desensitizing
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs