Levels of PainNCT02211547
Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients
A study testing Epic 10 Diode Laser by Biolase Inc. in people with Levels of Pain, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Levels of Pain
- What is being tested?
- Epic 10 Diode Laser by Biolase Inc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Absence of acute or chronic dental disease and periodontal disease
- Free from severe systemic disease
- No fixed orthodontic appliances currently placed
- No ankylosis or tooth implants within dentition
- No analgesic drug consumption for 48 hours preceding the study and during the study, a minimum age of 6 years
Who cannot join
- Presence of a diastema where the separator would be placed
- Conditions that could alter nociception, such as current or previous use of anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral contraceptives
- Any medical conditions or medications that may contraindicate use of certain light/laser sources such as low level laser therapy (LLLT)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado, Pediatric Dental Center
Aurora, Colorado, 80045
About this study
The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. To test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS). Patients will be randomly assigned to one of three groups: treatment, placebo, and control. The aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.
- Conditions
- Levels of Pain
- Being tested
- Epic 10 Diode Laser by Biolase Inc., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epic 10 Diode Laser by Biolase Inc.Device
Also called Epic 10 Diode Laser by Biolase Inc. (Irvine, CA), Product Code: GEX,ILY, Regulatory Class: II, Regulation number: 878.4810, 510(K)
PlaceboOther
Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No treatment to be rendered following separator placement. |
| Placebo | Placebo comparator | Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place). Receives: Other: Placebo |
| Treatment | Experimental | Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place). Receives: Device: Epic 10 Diode Laser by Biolase Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced by the patient
Pain will be assessed via a 10 cm non-hashed visual analog scale at two time points, immediately after placement of the elastomeric separators (time 0), and approximately 24 hours after placement when the patient returns to the clinic for separator removal.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionOct 2015 (estimated)
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levels of PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Linda Murzyn-Dantzer, DMD,MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211547
- Sponsor's protocol ID
- 13-3091
- Status last verified
- Jan 2017
- First submitted
- 5 Aug 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02211547
- Acronym / sponsor ID
- 13-3091
- Conditions
- Levels of Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. To test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS). Patients will be randomly assigned to one of three groups: treatment, placebo, and control. The aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No treatment to be rendered following separator placement. |
| Placebo | Placebo comparator | Other: PlaceboSingle blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place). |
| Treatment | Experimental | Device: Epic 10 Diode Laser by Biolase Inc.Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Absence of acute or chronic dental disease and periodontal disease
- Free from severe systemic disease
- No fixed orthodontic appliances currently placed
- No ankylosis or tooth implants within dentition
- No analgesic drug consumption for 48 hours preceding the study and during the study, a minimum age of 6 years
Key exclusion criteria (3 listed)
- Presence of a diastema where the separator would be placed
- Conditions that could alter nociception, such as current or previous use of anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral contraceptives
- Any medical conditions or medications that may contraindicate use of certain light/laser sources such as low level laser therapy (LLLT)
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 |
|---|---|---|
| Epic 10 Diode Laser by Biolase Inc.Also: Epic 10 Diode Laser by Biolase Inc. (Irvine, CA), Product Code: GEX,ILY, Regulatory Class: II, Regulation number: 878.4810, 510(K) | Device | Treatment |
| PlaceboSingle blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place). | Other | Placebo |
Primary outcome
Pain experienced by the patient
Time frame: 24 hours
Pain will be assessed via a 10 cm non-hashed visual analog scale at two time points, immediately after placement of the elastomeric separators (time 0), and approximately 24 hours after placement when the patient returns to the clinic for separator removal.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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.
Linda Murzyn-Dantzer, DMD,MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epic 10 Diode Laser by Biolase Inc. in people with Levels of Pain, run by University of Colorado, Denver at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain experienced by the patient (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2017.