CPP-ACPF and Laser's Effect on Dentin Hypersensitivity

NCT03750851 | Completed DMC

• 1 other identifier: UFPara-005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

desensitizing treatment; dental hypersensitivity; CPPACPF; Low level laser therapy

Outcome Measures

Primary Outcomes (2)

• Efficacy of treatment in dental sensitivity intensity change as assessed by VAS

  Self reported dentin sensitivity intensity before and after desensitizing treatment. Giving an score for each tooth by marking in the Visual Analogue Scale (VAS) from 0-10 (0-no pain and 10-pain as bad as it can be). With lower values representing a better outcome.

  1 month

• Quality of life change

  Self reported dentin sensitivity intensity impact in the quality's of life before and after desensitizing treatment. By answering an specific questionnaire: Dentine Hypersensitivity Experience Questionnaire, measured in a likert scale from 7 to 1 (Where 7 is strongly agree and 1 is strongly disagree). With lower values representing a better outcome.

  1 month

Study Arms (4)

GPlacebo

PLACEBO COMPARATOR

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.

Other: Placebo

GCPPACPF

EXPERIMENTAL

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.

Other: CPPACPF

GLaser

EXPERIMENTAL

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.

Other: Laser

GLaserCPPACPF

EXPERIMENTAL

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.

Other: LaserCPPACPF

Interventions

Placebo 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.

GPlacebo

CPPACPF 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.

GCPPACPF

Laser 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.

GLaser

LaserCPPACPF 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.

GLaserCPPACPF

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The presence of at least two hypersensitive teeth;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Para's Federal University

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Lasers

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Cecy M Silva, PhD

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Clinical Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 23, 2018
• Study Start: June 11, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 14, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

BR (1)