search
Back to results

Cyanoacrylate and Laser and Dentin Sensitivity (Cyano-laser)

Primary Purpose

Dentin Hypersensitivity, Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cyanoacrylate
Laser
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring dentin hypersensitivity, cyanoacrylate, laser

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. patients should be in good general and dental health;
  2. present complaints of dental sensitivity to cold, sweet, acidic foods and brushing;
  3. present complaints of pain in teeth located in different quadrants;
  4. manifest pain or discomfort upon application of the triple syringe air jet;
  5. not be in current use of desensitizing agents.

Exclusion Criteria:

  1. presence of extensive restorations and carious lesions in the sensitive teeth;
  2. undergoing orthodontic treatment;
  3. frequent use of analgesics, antidepressants and anti-inflammatory drugs;
  4. presence of gingival inflammation;
  5. non-consent of patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cyanoacrylate

    Laser

    Arm Description

    3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth

    3 Low intensity laser application (48 hour interval). The application of 1Joule/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm)

    Outcomes

    Primary Outcome Measures

    Change of the Pain Sensitivity
    Change in pain experienced by the participants was calculated as the difference between baseline level of pain sensitivity and after 180 days. Pain was recorded using a numerical pain assessment scale with range between 0 (no pain) to 10 (worst possible pain). The higher the numbering the worse the result.

    Secondary Outcome Measures

    Quality of Life Improvement
    Difference between the level of quality of life - Oral Health Impact Profile "OHIP" at baseline and 180 days. OHIP-14 total scale ranges from 0 to 56 points with higher scores indicating a poorer oral health-related quality of life. The response format uses a Likert-type frequency scale such as follows: very often = 4, fairly often = 3, occasionally = 2, hardly ever = 1, never = 0. Total score is obtained by summing the response codes of the 14 items constituting the measure.

    Full Information

    First Posted
    April 20, 2010
    Last Updated
    August 13, 2020
    Sponsor
    Federal University of São Paulo
    Collaborators
    Federal University of the Valleys of Jequitinhonha and Mucuri
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01111474
    Brief Title
    Cyanoacrylate and Laser and Dentin Sensitivity
    Acronym
    Cyano-laser
    Official Title
    Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Federal University of the Valleys of Jequitinhonha and Mucuri

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity: cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment (LILT). As the cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this product is equally effective as the laser treatment.
    Detailed Description
    The present study included 62 patients (15 male and 47 females, aged 12 to 60 years). The initial cervical dentin hypersensitivity was checked throughout a thermal test (air blast). The 434 teeth included were that with a score ≥5 in a numerical scale rating of pain. Teeth were randomly assigned according quadrants (split mouth design) - 216 were allocated to LILT group and 218 for the Super Bonder® group. Thermal tests with a tetrafluoroethane spray (Endo-Ice®) and air blast were performed and considered as baseline. Pain parameters were recorded using a numerical scale rating with 24 hours, 30, 90 and 180 days after the interventions. Quality of life of the patients was also assessed with the use of OHIP-14 at baseline and after 180 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dentin Hypersensitivity, Dentin Sensitivity
    Keywords
    dentin hypersensitivity, cyanoacrylate, laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cyanoacrylate
    Arm Type
    Active Comparator
    Arm Description
    3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth
    Arm Title
    Laser
    Arm Type
    Active Comparator
    Arm Description
    3 Low intensity laser application (48 hour interval). The application of 1Joule/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm)
    Intervention Type
    Other
    Intervention Name(s)
    Cyanoacrylate
    Other Intervention Name(s)
    Superbonder
    Intervention Description
    3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth
    Intervention Type
    Radiation
    Intervention Name(s)
    Laser
    Other Intervention Name(s)
    LILT
    Intervention Description
    This process was conducted three times with an interval of 48 hours between applications, according to laser's manufacturer advice Clean Line Easy Laser - LILT®, Clean Line Easy Laser Doctor Dental Products Industry LTDA, BRA). For dentin hypersensitivity, the application of 1Joule/cm^2 is recommended for eight seconds at three points along the dental neck, using the infrared wavelength (795nm).
    Primary Outcome Measure Information:
    Title
    Change of the Pain Sensitivity
    Description
    Change in pain experienced by the participants was calculated as the difference between baseline level of pain sensitivity and after 180 days. Pain was recorded using a numerical pain assessment scale with range between 0 (no pain) to 10 (worst possible pain). The higher the numbering the worse the result.
    Time Frame
    Baseline and 180 days
    Secondary Outcome Measure Information:
    Title
    Quality of Life Improvement
    Description
    Difference between the level of quality of life - Oral Health Impact Profile "OHIP" at baseline and 180 days. OHIP-14 total scale ranges from 0 to 56 points with higher scores indicating a poorer oral health-related quality of life. The response format uses a Likert-type frequency scale such as follows: very often = 4, fairly often = 3, occasionally = 2, hardly ever = 1, never = 0. Total score is obtained by summing the response codes of the 14 items constituting the measure.
    Time Frame
    Baseline and 180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients should be in good general and dental health; present complaints of dental sensitivity to cold, sweet, acidic foods and brushing; present complaints of pain in teeth located in different quadrants; manifest pain or discomfort upon application of the triple syringe air jet; not be in current use of desensitizing agents. Exclusion Criteria: presence of extensive restorations and carious lesions in the sensitive teeth; undergoing orthodontic treatment; frequent use of analgesics, antidepressants and anti-inflammatory drugs; presence of gingival inflammation; non-consent of patient.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olga D. Flecha, pHD student
    Organizational Affiliation
    UNIFESP - Federal University of São Paulo, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cyanoacrylate and Laser and Dentin Sensitivity

    We'll reach out to this number within 24 hrs