PainNCT03023761
Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy
A study testing low level laser in people with Pain, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- low level laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteIran
- Study dates
- Jan 2017to Jul 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients requiring endodontic retreatments in the posterior teeth
Who cannot join
- systemic diseases psychologic disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti University
Tehran
Saranaz azari marhabi, 09190129151
About this study
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy
Read the detailed description
In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group. In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea) with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square test between two groups. The effects of different variables on the post-operative pain experience were also studied by means of Logistic regression.
- Conditions
- Pain
- Being tested
- low level laser, laser sham
- Keywords
- Endodontic retreatments, Low level laser, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laserDevice
low level laser irradiation
laser shamDevice
laser without irradiation
| Study group | Role | What they receive |
|---|---|---|
| low level laser | Active comparator | A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group Receives: Device: low level laser |
| laser sham | Placebo comparator | In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Receives: Device: laser sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of pain after low level laser irradiation
Measured: baseline and 4, 8, 12, 24 and 48 hours after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saranaz azari-marhabi, Shahid Beheshti University
- Investigators
- mohammad asnaashari, Study chair, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023761
- Sponsor's protocol ID
- 123
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy
- ClinicalTrials.gov ID
- NCT03023761
- Acronym / sponsor ID
- 123
- Conditions
- Pain
- Keywords
- Endodontic retreatments, Low level laser, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Jan 2017 (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.
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy
Detailed description
In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group. In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea) with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square test between two groups. The effects of different variables on the post-operative pain experience were also studied by means of Logistic regression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low level laser | Active comparator | Device: low level laserA single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group |
| laser sham | Placebo comparator | Device: laser shamIn the control group patients received placebo laser to eliminate the probable psychological effects of laser. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients requiring endodontic retreatments in the posterior teeth
Key exclusion criteria (1 listed)
- systemic diseases psychologic disorders
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 |
|---|---|---|
| low level laserlow level laser irradiation | Device | low level laser |
| laser shamlaser without irradiation | Device | laser sham |
Primary outcome
reduction of pain after low level laser irradiation
Time frame: baseline and 4, 8, 12, 24 and 48 hours after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
mohammad asnaashari study chair
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser in people with Pain, run by Shahid Beheshti University at 1 site in Iran.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact saranaz azari-marhabi (09190129151, saranazazari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of pain after low level laser irradiation (time frame: baseline and 4, 8, 12, 24 and 48 hours after the treatment). 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 18 Jan 2017.