NCT01111474

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

August 17, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

April 20, 2010

Results QC Date

February 13, 2012

Last Update Submit

August 13, 2020

Conditions

Keywords

dentin hypersensitivitycyanoacrylatelaser

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Life Improvement

    Baseline and 180 days

Study Arms (2)

Cyanoacrylate

ACTIVE COMPARATOR

3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth

Other: Cyanoacrylate

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)

Radiation: Laser

Interventions

3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth

Also known as: Superbonder
Cyanoacrylate
LaserRADIATION

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).

Also known as: LILT
Laser

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

CyanoacrylatesLasers

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and AgricultureOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title
Dr. Olga Dumont Flecha - PHD student
Organization
Federal University of São Paulo

Study Officials

  • Olga D. Flecha, pHD student

    UNIFESP - Federal University of São Paulo, Brazil

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 27, 2010

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

August 17, 2020

Results First Posted

August 17, 2020

Record last verified: 2020-08