Clinical trial NCT03750851: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: desensitizing treatment
dental hypersensitivity
CPPACPF
Low level laser therapy
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Efficacy of treatment in dental sensitivity intensity change as assessed by VAS
timeFrame: 1 month
measure: Quality of life change
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Para's Federal University
state: Pará
Study officials:
affiliation: clinical professor
name: Cecy M Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: