- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03750851
CPP-ACPF and Laser's Effect on Dentin Hypersensitivity
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pará
-
Belém, Pará, Brazil, 66075-110
- Para's Federal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of treatment in dental sensitivity intensity change as assessed by VAS
Time Frame: 1 month
|
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
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFPara-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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