Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

NCT ID: NCT03637426

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-08-03

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).

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

nano-hydroxyapatite

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Laser

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Laser + nano-hydroxyapatite

Intervention Type: OTHER

GLASERnHAP first received laser application and subsequently the application of nanohydroxyapatite according to the manufacturer's recommendations.

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Laser + nano-hydroxyapatite

GLASERnHAP first received laser application and subsequently the application of nanohydroxyapatite according to the manufacturer's recommendations.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Low level laser therapy; dentin desensitization agent based on nano-hydroxyapatite

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva, pHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Para

Locations

Federal University of Pará

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-004

Identifier Type: -

Identifier Source: org_study_id