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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Hypersensitivity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belém, Pará, Brazil, 66075-110
      • Universidade Federal do Para

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group G1; Photon Laser III-DMC (without radiation emission) + My First- Colgate	Other: Photon Laser III-DMC (without radiation emission) + My First- Colgate; 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.
Experimental: Group G2; Photon Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK	Other: Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK; 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.
Experimental: Group G3; Photon Laser III-DMC (with irradiation emission) + My First- Colgate	Radiation: Photon Laser III-DMC (with irradiation emission) + My First- Colgate; 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.
Experimental: Group G4; Photon Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK	Combination product: Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Para

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: UFPara-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No