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| Name | Class |
|---|---|
| Federal University of the Valleys of Jequitinhonha and Mucuri | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanoacrylate | Active Comparator | 3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth |
|
| Laser | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate | Other | 3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga D. Flecha, pHD student | UNIFESP - Federal University of São Paulo, Brazil | Principal Investigator |
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The patients which had not achieved an initial level of hypersensitivity were excluded from the trial before assignment to the groups.
The patients with dentin hypersensitivity were recruited through posters and folders provided at the Dental Clinics, schools, gyms and drugstores.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | In this split mouth study, teeth from the participants were randomly assigned according to quadrants, to either receive Cyanoacrilate (Superbonder) or Laser (LILT). Cyanoacrylate: 3 applications with a microbrush (48 hour interval). Laser: 3 Low intensity laser application (48 hour interval). The application of 1Joules/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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62 participants contributed with 434 teeth in a split mouth design: 216 teeth were treated with laser and 218 teeth were treated with cyanoacrylate.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | In this split mouth study, teeth from the participants were randomly assigned according to quadrants, to either receive Cyanoacrylate (Superbonder) or Laser (LILT). Cyanoacrylate: 3 applications of Superbonder (48 hours interval) at the cervical region of the sensitive tooth. LILT: 3 Low intensity laser application (48 hour interval). The application of 1Joules/cm^2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (795nm) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 62 participants contributed with 434 teeth in a split mouth design: 216 teeth were treated with laser and 218 teeth were treated with cyanoacrylate. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 180 days | teeth | teeth |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyanoacrylate | 3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olga Dumont Flecha - PHD student | Federal University of São Paulo | 38 35326082 | olgaflecha@gmail.com |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Laser | Radiation | 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). |
|
|
| Baseline and 180 days |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
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) |
|
|
| 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. | 62 participants contributed with 62 questionnaires in each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 180 days |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Laser | 3 Low intensity laser application (48 hour interval). The application of 1J/cm2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (660nm) | 0 | 62 | 0 | 62 |
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| D009570 |
| Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |