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
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring dentin hypersensitivity, cyanoacrylate, laser
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.
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
NCT ID
NCT01111474
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
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
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