Pediatric AnesthesiaNCT04243811
Efficacy of Low Level Laser Therapy on İnjection Pain
A study testing Diode Laser and topical anesthesia in people with Pediatric Anesthesia and Low Level Laser Theraphy, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to compare the pain during needle insertion and injection in supraperiosteal anesthesia with either topical anesthesia (control) or LLTT (experimental). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Anesthesia, Low Level Laser Theraphy
- What is being tested?
- Diode Laser and topical anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 15 Aug 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In need of treatment of right and left molar teeth of maxilla,
- Does not have any systemic disorder,
- High level of communication that can provide logical answers to the questions we ask
- With parental consent,
- Volunteers who want to participate in the research
- 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic
Who cannot join
- No need for treatment of right and left molar teeth of maxilla,
- Has a systemic condition
- Low level of communication that cannot provide reasonable answers to the questions we ask
- Without parental consent
- Do not want to participate voluntarily in the research
- Do not attend a check-in
- Patients not in the 6-12 age group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University Faculty of Dentistry
Istanbul, 34959
About this study
Official title: Efficacy of Low Level Laser Therapy in the Management of Injection Pain During Supraperiosteal Anesthesia in Children: A Randomize Clinical Trial
The purpose of this study was to compare the pain during needle insertion and injection in supraperiosteal anesthesia with either topical anesthesia (control) or LLTT (experimental).
- Conditions
- Pediatric Anesthesia, Low Level Laser Theraphy
- Being tested
- Diode Laser, topical anesthesia
- Keywords
- pediatric patient, injection pain, lllt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode LaserDevice
LLLT with dental needle for local anesthesia during dental treatment
topical anesthesiaOther
topical anesthesia with dental needle for local anesthesia during dental treatment
| Study group | Role | What they receive |
|---|---|---|
| laser group | Experimental | local anesthesia applyed with 940 nm diode laser Receives: Device: Diode Laser |
| conventional group | Active comparator | local anesthesia applyed with topical anesthesia Receives: Other: topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Rating Scale (PRS)
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").
Measured: 1 year
Face, Legg, Cry, Consolability Scale (FLACC)
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start15 Nov 2020 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Why it stopped: Due to the technical problem in the laser device,it has not started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem yildirim, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243811
- Sponsor's protocol ID
- 2018/47
- Status last verified
- May 2020
- First submitted
- 24 Jan 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Level Laser Therapy in the Management of Injection Pain During Supraperiosteal Anesthesia in Children: A Randomize Clinical Trial
- ClinicalTrials.gov ID
- NCT04243811
- Acronym / sponsor ID
- 2018/47
- Conditions
- Pediatric Anesthesia, Low Level Laser Theraphy
- Keywords
- pediatric patient, injection pain, lllt
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the technical problem in the laser device,it has not started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 28 Jan 2020 (actual)
- 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 purpose of this study was to compare the pain during needle insertion and injection in supraperiosteal anesthesia with either topical anesthesia (control) or LLTT (experimental).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser group | Experimental | Device: Diode Laserlocal anesthesia applyed with 940 nm diode laser |
| conventional group | Active comparator | Other: topical anesthesialocal anesthesia applyed with topical anesthesia |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- In need of treatment of right and left molar teeth of maxilla,
- Does not have any systemic disorder,
- High level of communication that can provide logical answers to the questions we ask
- With parental consent,
- Volunteers who want to participate in the research
Key exclusion criteria (7 listed)
- No need for treatment of right and left molar teeth of maxilla,
- Has a systemic condition
- Low level of communication that cannot provide reasonable answers to the questions we ask
- Without parental consent
- Do not want to participate voluntarily in the research
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 |
|---|---|---|
| Diode LaserLLLT with dental needle for local anesthesia during dental treatment | Device | laser group |
| topical anesthesiatopical anesthesia with dental needle for local anesthesia during dental treatment | Other | conventional group |
Primary outcome
Wong-Baker Faces Pain Rating Scale (PRS)
Time frame: 1 year
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").
Face, Legg, Cry, Consolability Scale (FLACC)
Time frame: 1 year
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.
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 6 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser and topical anesthesia in people with Pediatric Anesthesia and Low Level Laser Theraphy, run by Okan University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 6 May 2020. 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 Turkey (Türkiye). 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. 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?
Wong-Baker Faces Pain Rating Scale (PRS) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 6 May 2020.