CPP-ACPF and Laser's Effect on Dentin Hypersensitivity

NCT ID: NCT03750851

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2018-12-14

Brief Summary

The aim of this study was to evaluate the effect of casein phosphopeptide amorphous calcium phosphate fluoride paste (CPP-ACPF) associated with low level laser therapy (LLLT) in the symptomatology and on the quality of life of the individuals with 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; GCPPACPF - positioning of the laser tip without light emission + CPP-ACPF application; GLaser - laser tip positioning with light emission + placebo dentifrice; GLaserCPPACPF - positioning and light emission of the laser beam + CPP-ACPF.

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. At each point it was applied 60 J / cm², for 16 seconds. Three laser's sessions were applied with a time interval of 24 hours between them. GLaserCPPACPF first received the CPPACPF application and then the laser application according to the manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated with a tester (MMOptics Ltda®, Brazil).

The GCPPACPF volunteers were submitted to the application of the CPPACPF'S containing tooth paste MI Paste Plus™ (Recaldent™, GC América, USA) on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) for 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the desensitizing gel during 20 seconds on each tooth, according to the manufacturer's specifications. GPlacebo followed the same protocol used in GCPPACPF. In addition to the desensitizing treatments, all GCPPACPF and GPlacebo volunteers received the positioning of the laser tip to mimic the light emission produced in GLaser and GLaserCPPACPF. The noise emitted by the laser device was mimic through the sound reproduction of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, 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 water soluble gel without addition any desensitizing agent (K-Y®, Johnson \& Johnson, Brazil) was applied to hypersensitive dentin. 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, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson \& Johnson, Brazil) was applied to hypersensitive dentin. 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, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.

GCPPACPF

In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.

Group Type: EXPERIMENTAL

CPPACPF

Intervention Type: OTHER

In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.

GLaser

In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. 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 3 sessions with a time interval of 24 hours between them.

Group Type: EXPERIMENTAL

Laser

Intervention Type: OTHER

In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. 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 3 sessions with a time interval of 24 hours between them.

GLaserCPPACPF

In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.

Group Type: EXPERIMENTAL

LaserCPPACPF

Intervention Type: OTHER

In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.

Interventions

Placebo

In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson \& Johnson, Brazil) was applied to hypersensitive dentin. 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, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.

Intervention Type: OTHER

CPPACPF

In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.

Intervention Type: OTHER

Laser

In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. 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 3 sessions with a time interval of 24 hours between them.

Intervention Type: OTHER

LaserCPPACPF

In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The presence of at least two hypersensitive teeth;

Exclusion Criteria

• Milk's proteins allergy;
• Systemic diseases;
• Teeth with carious lesions or pulpitis;
• Teeth with defective restorations;
• Teeth with 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

PhD Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

clinical professor

Locations

Para's Federal University

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-005

Identifier Type: -

Identifier Source: org_study_id