- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111474
Cyanoacrylate and Laser and Dentin Sensitivity (Cyano-laser)
August 13, 2020 updated by: Olga Flecha, Federal University of São Paulo
Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cyanoacrylate
3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth
|
3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth
Other Names:
|
Active Comparator: Laser
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)
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the Pain Sensitivity
Time Frame: Baseline and 180 days
|
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.
|
Baseline and 180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Improvement
Time Frame: Baseline and 180 days
|
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.
|
Baseline and 180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olga D. Flecha, pHD student, UNIFESP - Federal University of Sao Paulo, Brazil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
April 20, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 27, 2010
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- odf2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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