Trial Outcomes & Findings for Cyanoacrylate and Laser and Dentin Sensitivity (NCT NCT01111474)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

Baseline and 180 days

Results posted on

2020-08-17

Participant Flow

The patients with dentin hypersensitivity were recruited through posters and folders provided at the Dental Clinics, schools, gyms and drugstores.

The patients which had not achieved an initial level of hypersensitivity were excluded from the trial before assignment to the groups.

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	74
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Lost to Follow-up	12

Baseline Characteristics

Cyanoacrylate and Laser and Dentin Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=62 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)
Age, Continuous	31.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex/Gender, Customized Male	15 participants n=5 Participants
Sex/Gender, Customized Female	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 180 days

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

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.

Outcome measures

Outcome measures
Measure	Cyanoacrylate n=218 teeth 3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth	Laser n=216 teeth 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)
Change of the Pain Sensitivity Baseline	7.77 score on a scale Standard Deviation 1.7	7.49 score on a scale Standard Deviation 1.7
Change of the Pain Sensitivity 180 days	2.57 score on a scale Standard Deviation 2.9	2.36 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and 180 days

Population: 62 participants contributed with 62 questionnaires in each group.

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.

Outcome measures

Outcome measures
Measure	Cyanoacrylate n=62 Participants 3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth	Laser n=62 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)
Quality of Life Improvement Baseline	16.87 score on a scale Standard Deviation 9.1	16.87 score on a scale Standard Deviation 9.1
Quality of Life Improvement 180 days	12.05 score on a scale Standard Deviation 8.0	12.05 score on a scale Standard Deviation 8.0

Adverse Events

Cyanoacrylate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Olga Dumont Flecha - PHD student

Federal University of São Paulo

Phone: 38 35326082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place