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

Primary Purpose

Dental Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photon Laser III-DMC (without radiation emission) + My First- Colgate
Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK
Photon Laser III-DMC (with irradiation emission) + My First- Colgate
Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Hypersensitivity

Eligibility Criteria

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

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.

Sites / Locations

  • Universidade Federal do Pará

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Group G1

Group G2

Group G3

Group G4

Arm Description

Photon Laser III-DMC (without radiation emission) + My First- Colgate

Photon Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK

Photon Laser III-DMC (with irradiation emission) + My First- Colgate

Photon Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2020
Last Updated
November 23, 2020
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT04642001
Brief Title
Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions
Official Title
Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
November 5, 2020 (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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Hypersensitivity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group G1
Arm Type
Other
Arm Description
Photon Laser III-DMC (without radiation emission) + My First- Colgate
Arm Title
Group G2
Arm Type
Experimental
Arm Description
Photon Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK
Arm Title
Group G3
Arm Type
Experimental
Arm Description
Photon Laser III-DMC (with irradiation emission) + My First- Colgate
Arm Title
Group G4
Arm Type
Experimental
Arm Description
Photon Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK
Intervention Type
Other
Intervention Name(s)
Photon Laser III-DMC (without radiation emission) + My First- Colgate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Photon Laser III-DMC (with irradiation emission) + My First- Colgate
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK
Intervention Description
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.
Primary Outcome Measure Information:
Title
dentin sensitivity
Description
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.
Time Frame
30 days after the end of treatment

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: 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.
Facility Information:
Facility Name
Universidade Federal do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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