Dentin HypersensitivityCyano-laserNCT01111474

Cyanoacrylate and Laser and Dentin Sensitivity

A study testing Cyanoacrylate and Laser in people with Dentin Hypersensitivity and Dentin Sensitivity, run by Federal University of São Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Hypersensitivity, Dentin Sensitivity
What is being tested?: Cyanoacrylate and Laser
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: No sites listed yet
Study dates: Aug 2008to Feb 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity

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.

Read the 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.

Conditions: Dentin Hypersensitivity, Dentin Sensitivity
Being tested: Cyanoacrylate, Laser
Keywords: dentin hypersensitivity, cyanoacrylate, laser
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CyanoacrylateOther
Also called Superbonder
3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth
LaserRadiation
Also called LILT
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).

Study groups in NCT01111474
Study group	Role	What they receive
Cyanoacrylate	Active comparator	3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth Receives: 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) Receives: Radiation: Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 180 days

Secondary outcomes (1)

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.
Measured: Baseline and 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Feb 2009

First posted27 Apr 2010 (estimated)
Study startAug 2008
Primary completionDec 2008
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01111474
Sponsor's protocol ID: odf2008
Acronym: Cyano-laser
Status last verified: Aug 2020
First submitted: 20 Apr 2010
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Dentin Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity
ClinicalTrials.gov ID: NCT01111474
Acronym / sponsor ID: Cyano-laser / odf2008
Conditions: Dentin Hypersensitivity, Dentin Sensitivity
Keywords: dentin hypersensitivity, cyanoacrylate, laser
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Collaborators: Federal University of the Valleys of Jequitinhonha and Mucuri
Study start: Aug 2008
Primary completion: Dec 2008 (actual)
Study completion: Feb 2009 (actual)
First posted: 27 Apr 2010 (estimated)
Results: Posted 17 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cyanoacrylate	Active comparator	Other: Cyanoacrylate3 applications of cyanoacrylate (48 hours interval)at the cervical region of the sensitive tooth
Laser	Active comparator	Radiation: Laser3 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)

Who may qualify

Ages: 12 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CyanoacrylateAlso: Superbonder3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth	Other	Cyanoacrylate
LaserAlso: LILTThis 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).	Radiation	Laser

Primary outcome

Change of the Pain Sensitivity
Time frame: 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.

1 secondary outcome

Quality of Life Improvement
Time frame: Baseline and 180 days

Results and safety

Results posted to the registry on 17 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	74	62

Primary outcome: Change of the Pain Sensitivity

Time frame: Baseline and 180 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Cyanoacrylate n = 62	Laser n = 62
Baseline	7.77 (1.7)	7.49 (1.7)
180 days	2.57 (2.9)	2.36 (2.7)

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cyanoacrylate	0 of 62 (0%)	0 of 62 (0%)	Not reported
Laser	0 of 62 (0%)	0 of 62 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dentin Hypersensitivity

Not yet recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
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Tooth Discoloration, Tooth Staining
Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olga D. Flecha, pHD student principal investigator

UNIFESP - Federal University of São Paulo, Brazil

Questions about this trial

What is this clinical trial studying?

A study testing Cyanoacrylate and Laser in people with Dentin Hypersensitivity and Dentin Sensitivity, run by Federal University of São Paulo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the Pain Sensitivity (time frame: Baseline and 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01111474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.