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CPP-ACPF and Laser's Effect on Dentin Hypersensitivity

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
CPPACPF
Laser
LaserCPPACPF
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring desensitizing treatment, dental hypersensitivity, CPPACPF, Low level laser therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Para's Federal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

GPlacebo

GCPPACPF

GLaser

GLaserCPPACPF

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2018
Last Updated
April 15, 2019
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT03750851
Brief Title
CPP-ACPF and Laser's Effect on Dentin Hypersensitivity
Official Title
CPP-ACPF and Low Level Laser Therapy Effect on Symptomatology and Quality of Life of People With Dentin Hypersensitivity: A Clinical, Randomized, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 7, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
desensitizing treatment, dental hypersensitivity, CPPACPF, Low level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GPlacebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
GCPPACPF
Arm Type
Experimental
Arm Description
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.
Arm Title
GLaser
Arm Type
Experimental
Arm Description
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.
Arm Title
GLaserCPPACPF
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
CPPACPF
Intervention Description
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
Intervention Name(s)
Laser
Intervention Description
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
Intervention Name(s)
LaserCPPACPF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of treatment in dental sensitivity intensity change as assessed by VAS
Description
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.
Time Frame
1 month
Title
Quality of life change
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva, PhD
Organizational Affiliation
clinical professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Para's Federal University
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CPP-ACPF and Laser's Effect on Dentin Hypersensitivity

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