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Completed

NCT Number: NCT03637426

Effect of Nano-hydroxyapatite and LASER on Dentin Hypersensitivity

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Pará

Belém, Pará, 66075-110, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser

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.

Other names: Low level laser therapy

nano-hydroxyapatite

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

Other names: dentin desensitization agent based on nano-hydroxyapatite

Laser + nano-hydroxyapatite

Other

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

Placebo

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.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Effect of Nano-hydroxyapatite and Low-level Laser Therapy on Dentin Hypersensitivity Control: Clinical, Randomized, Double-blind, Placebo-controlled Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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