Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions

Study Overview
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Brief Summary
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This randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.

Official Title
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Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.

Conditions
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Dental Hypersensitivity

Intervention / Treatment
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* Other: Photon Laser III-DMC (without radiation emission) + My First- Colgate
* Other: Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK
* Radiation: Photon Laser III-DMC (with irradiation emission) + My First- Colgate
* Combination Product: Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 50 years Good general health Dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (EVA) Presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe) Exposed root surface caused by abrasion, erosion or gum recession Exclusion Criteria: Volunteers using analgesic medication Presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease Patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months Patient with fixed orthodontic appliances Drug users or pregnant women were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group G1<br>Photon Laser III-DMC (without radiation emission) + My First- Colgate | Other: Photon Laser III-DMC (without radiation emission) + My First- Colgate<br>* Positioning of the FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.<br>|
| Experimental: Group G2<br>Photon Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK | Other: Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK<br>* Positioning of FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.<br>|
| Experimental: Group G3<br>Photon Laser III-DMC (with irradiation emission) + My First- Colgate | Radiation: Photon Laser III-DMC (with irradiation emission) + My First- Colgate<br>* Emission of FBM therapy (Photon Laser III / DMC), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.<br>|
| Experimental: Group G4<br>Photon Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK | Combination Product: Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK<br>* Emission of FBM therapy (Photon Laser III / DMC), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dentin sensitivity | evaluation of dentinal sensitivity during treatment and one month after its end, by means of tactile and evaporative stimuli according to the visual analog scale with values from 0 to 10, with higher values indicating a worse level of pain. | 30 days after the end of treatment |