Cyano-laser: Cyanoacrylate and Laser and Dentin Sensitivity

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01111474
• Collaborator: Federal University of the Valleys of Jequitinhonha and Mucuri (Other)
• Enrollment: 62
• Arms: 2
• Duration (Months): 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity; Dentin Sensitivity	Other: Cyanoacrylate; Radiation: Laser	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cyanoacrylate 3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth	Other: Cyanoacrylate; 3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth; Other Names: Superbonder
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)	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).; Other Names: LILT

Outcome Measures

Primary Outcome Measures

1. Change of the Pain Sensitivity [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.

Secondary Outcome Measures

1. Quality of Life Improvement [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of São Paulo
• Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

• Principal Investigator: Olga D. Flecha, pHD student, UNIFESP - Federal University of São Paulo, Brazil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olga Flecha, PHD student, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01111474
• Other Study ID Numbers: odf2008
• First Posted: Apr 27, 2010
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Olga Flecha, PHD student, Federal University of São Paulo: dentin hypersensitivity; cyanoacrylate; laser
• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity

Study Results

Participant Flow

Recruitment Details	The patients with dentin hypersensitivity were recruited through posters and folders provided at the Dental Clinics, schools, gyms and drugstores.
Pre-assignment Detail	The patients which had not achieved an initial level of hypersensitivity were excluded from the trial before assignment to the groups.

Arm/Group Title	All Study Participants
Arm/Group Description	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)
Period Title: Overall Study
STARTED	74
COMPLETED	62
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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)
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (10.7)
Sex/Gender, Customized (participants) [Number]
Male	15 24.2%
Female	47 75.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

62 participants contributed with 434 teeth in a split mouth design: 216 teeth were treated with laser and 218 teeth were treated with cyanoacrylate.

Arm/Group Title	Cyanoacrylate	Laser
Arm/Group 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)
Measure Participants	62	62
Measure teeth	218	216
Baseline	7.77 (1.7)	7.49 (1.7)
180 days	2.57 (2.9)	2.36 (2.7)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

62 participants contributed with 62 questionnaires in each group.

Arm/Group Title	Cyanoacrylate	Laser
Arm/Group 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)
Measure Participants	62	62
Baseline	16.87 (9.1)	16.87 (9.1)
180 days	12.05 (8.0)	12.05 (8.0)

Adverse Events

Arm/Group Title	Cyanoacrylate		Laser
Arm/Group 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 1J/cm2 was performed for eight seconds at three points along the dental neck, using the infrared wavelength (660nm)
All Cause Mortality
	Cyanoacrylate		Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cyanoacrylate		Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Cyanoacrylate		Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.