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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01111474
Other study ID # odf2008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2008
Est. completion date February 2009

Study information

Verified date August 2020
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Other:
Cyanoacrylate
3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth
Radiation:
Laser
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).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Federal University of the Valleys of Jequitinhonha and Mucuri

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 180 days
Secondary 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. Baseline and 180 days
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