Pain Relief Caused by Placing Orthodontic SeparatorsNCT04532476
Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators
A study testing Low level laser therapy in people with Pain Relief Caused by Placing Orthodontic Separators, run by University Hospital Rijeka at 1 site in Croatia.
Trial summary
It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Relief Caused by Placing Orthodontic Separators
- What is being tested?
- Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Mar 2020to 1 Jul 2020
- 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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -patients aged between 12-19 years referred for orthodontic treatment, no previous orthodontic treatment, good general health , permanent dentition including second molars erupted, intact first maxillary permanent molars, good interproximal contacts on all maxillary first permanent molars, healty periodontal tissues ( gingival index=0, plaque index<1, probing depths<3mm, no peridontal attachment loss and no radiographic evidence of periodontal bone loss)
Who cannot join
- gingivitis/ periodontitis
- interproximal fillings
- missing teeth
- crowding or spacing in premolar or molar area
- severe systemic disease
- antibiotics or analgesics prescribed 15 days prior/during study
Trial locations and contacts
1 site in 1 country.
About this study
It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment.
Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled study. Four elastomeric separators were placed, mesially and distally to the upper first molar on each side. The right side of the upper jaw was treated with low-power diode laser, and the left side was a placebo, same treatment with laser switched off. Two doses of PBM therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the questionnaire immediately after the placement of separators and before 1st laser treatment (TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At each evaluation period, the degree of pain was scored twice, one for each side.
Read the detailed description
Placing elastomeric separators is a part of the orthodontic treatment to create space for the orthodontic bands. This initial tooth displacement induces pain and instant release bio-chemical mediators such as prostaglandin-E2, substance P and interleukin 1-beta.
It has been reported that 90% of the patients experience pain in at least one part of the orthodontic treatment. Pain starts two hours after application of orthodontic fixed appliance, raises over the next 24-36 hours, starts to decrease on day 3, and disappears within 6-7 days.There are two principal groups of methods for controlling orthodontic pain: pharmacolog-ical and non-pharmacological.
Laser photobiomodulation (PBM), also called low-level laser therapy (LLLT), is the ap-plication of the light to pathology to encourage tissue regeneration, decrease inflammation and relieving pain. The wavelength used for this purpose is in the red and infrared spectrum (600-1000nm). There is no complete understanding of the mechanisms behind PBM, however enormous upturn has been done in this part. PBM has an impact on molecular, cellular and tissue level.
Past studies in this field have demonstrated the opposite outcomes of PBM therapy on relieving the pain after the insertion of orthodontic separators. Part of the researches showed a positive effect in pain reduction and some presented no effect. The studies with positive outcomes have no consistent specification such as wavelength, dose, radiant exposure, irradiance, tip diameter, average power output, peak power (for gated mode), time, or position of the points of application.
Thus, the purpose of this study was to evaluate the efficiency of low-level diode laser in decreasing the level of pain at the beginning of an orthodontic treatment caused by elas-tomeric separators. The null hypothesis for this study was that no difference existed among laser-treated and placebo side in reducing pain caused by elastomeric separators.
Materials and methods Study design This is a single-blinded, placebo-controlled, split-mouth study. The design of this study was split-mouth to eliminate all components related to differences among subjects. The study was carried out at Department of Orthodontics, University Dental Clinic, Clinical Hospital Center Rijeka. Ethical approval was obtained from the Ethical Committee of the Clinical Hospital Center of Rijeka, Croatia (003-05/2/-1-/22, 2170-29-02/1-20-2).
Sample size The sample size was decided by the Power analysis (G*power 3.1.) based on the results from the previous study [29] and predicting study power of 0.95 and a significance level of 0.05. The program calculated the sample size of at least 22 participants.
Participants and inclusion criteria The sample included 22 participants (12 females and 10 males) Procedure Four elastomeric separators (American Orthodontics, Sheboygan, WI, USA were placed, mesially and distally to the upper first molar on each side, with a specially designed plier (Hu-Friedy, Chicago, IL, USA).
Both the laser and the placebo sides were applied by the diode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany), which was set at PDT mode (660nm) acu-puncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer.
It was determined in advance that the right side of the upper jaw was treated with laser, and the left side was placebo.
The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered, with total energy applied 43.2 J per tooth. Pla-cebo side was treated the same way with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so that participants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo. During the period of the laser irradiation, both the patient and orthodontist used goggles designed to block the laser's wavelength.
The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators.
- Being tested
- Low level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
Also called LLLT
Diode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany) was applied to the RIGHT side. Laser was set at PDT mode (660nm) acupuncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer.
The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered.
The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators.
| Study group | Role | What they receive |
|---|---|---|
| Laser treated side | Experimental | Group of 22 participants whose mucose around right maxillary permanent molar was treated with laser. Receives: Device: Low level laser therapy |
| Placebo side | Placebo comparator | Placebo side was LEFT side.It was treated the same way as right with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so participants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo. Receives: Device: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of pain
The pain was assessed with a visual analogue scale (VAS), which is a 100-mm-long hori-zontal line where one end corresponds to "no pain" and the other end indicates "worst pain possible." The participants filled out the questionnaire immediately after the placement of separators (TO) and before 1st laser treatment, 12 hours (T1), 24hours (T2) and just after 2nd laser treatment, 2 days (T3) and 3 days after the 1st treatment (T4) (Table 1). At each evalua-tion period, the degree of pain was scored twice, one for each side. Each patient was re-quired to indicate whether he/she had taken any analgesics during the recorded period.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start20 Mar 2020
- Primary completion20 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief Caused by Placing Orthodontic SeparatorsStudies 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
- Single group
- Model description
- This is a single -blinded, placebo controlled, split-mouth study. The design was split-mouth to eliminate all components related to differences among subjects.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Principal investigator, Vjera Perkovic, University Hospital Rijeka
- Investigators
- Senka Mestrovic, DDS, PhD, Study director, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532476
- Sponsor's protocol ID
- UHRijeka- laser
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators
- ClinicalTrials.gov ID
- NCT04532476
- Acronym / sponsor ID
- UHRijeka- laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 31 Aug 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.
It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment.
Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled study. Four elastomeric separators were placed, mesially and distally to the upper first molar on each side. The right side of the upper jaw was treated with low-power diode laser, and the left side was a placebo, same treatment with laser switched off. Two doses of PBM therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the questionnaire immediately after the placement of separators and before 1st laser treatment (TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At each evaluation period, the degree of pain was scored twice, one for each side.
Detailed description
Placing elastomeric separators is a part of the orthodontic treatment to create space for the orthodontic bands. This initial tooth displacement induces pain and instant release bio-chemical mediators such as prostaglandin-E2, substance P and interleukin 1-beta.
It has been reported that 90% of the patients experience pain in at least one part of the orthodontic treatment. Pain starts two hours after application of orthodontic fixed appliance, raises over the next 24-36 hours, starts to decrease on day 3, and disappears within 6-7 days.There are two principal groups of methods for controlling orthodontic pain: pharmacolog-ical and non-pharmacological.
Laser photobiomodulation (PBM), also called low-level laser therapy (LLLT), is the ap-plication of the light to pathology to encourage tissue regeneration, decrease inflammation and relieving pain. The wavelength used for this purpose is in the red and infrared spectrum (600-1000nm). There is no complete understanding of the mechanisms behind PBM, however enormous upturn has been done in this part. PBM has an impact on molecular, cellular and tissue level.
Past studies in this field have demonstrated the opposite outcomes of PBM therapy on relieving the pain after the insertion of orthodontic separators. Part of the researches showed a positive effect in pain reduction and some presented no effect. The studies with positive outcomes have no consistent specification such as wavelength, dose, radiant exposure, irradiance, tip diameter, average power output, peak power (for gated mode), time, or position of the points of application.
Thus, the purpose of this study was to evaluate the efficiency of low-level diode laser in decreasing the level of pain at the beginning of an orthodontic treatment caused by elas-tomeric separators. The null hypothesis for this study was that no difference existed among laser-treated and placebo side in reducing pain caused by elastomeric separators.
Materials and methods Study design This is a single-blinded, placebo-controlled, split-mouth study. The design of this study was split-mouth to eliminate all components related to differences among subjects. The study was carried out at Department of Orthodontics, University Dental Clinic, Clinical Hospital Center Rijeka. Ethical approval was obtained from the Ethical Committee of the Clinical Hospital Center of Rijeka, Croatia (003-05/2/-1-/22, 2170-29-02/1-20-2).
Sample size The sample size was decided by the Power analysis (G*power 3.1.) based on the results from the previous study [29] and predicting study power of 0.95 and a significance level of 0.05. The program calculated the sample size of at least 22 participants.
Participants and inclusion criteria The sample included 22 participants (12 females and 10 males) Procedure Four elastomeric separators (American Orthodontics, Sheboygan, WI, USA were placed, mesially and distally to the upper first molar on each side, with a specially designed plier (Hu-Friedy, Chicago, IL, USA).
Both the laser and the placebo sides were applied by the diode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany), which was set at PDT mode (660nm) acu-puncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer.
It was determined in advance that the right side of the upper jaw was treated with laser, and the left side was placebo.
The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered, with total energy applied 43.2 J per tooth. Pla-cebo side was treated the same way with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so that participants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo. During the period of the laser irradiation, both the patient and orthodontist used goggles designed to block the laser's wavelength.
The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single -blinded, placebo controlled, split-mouth study. The design was split-mouth to eliminate all components related to differences among subjects.
| Arm | Type | Receives |
|---|---|---|
| Laser treated side | Experimental | Device: Low level laser therapyGroup of 22 participants whose mucose around right maxillary permanent molar was treated with laser. |
| Placebo side | Placebo comparator | Device: Low level laser therapyPlacebo side was LEFT side.It was treated the same way as right with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so participants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -patients aged between 12-19 years referred for orthodontic treatment, no previous orthodontic treatment, good general health , permanent dentition including second molars erupted, intact first maxillary permanent molars, good interproximal contacts on all maxillary first permanent molars, healty periodontal tissues ( gingival index=0, plaque index<1, probing depths<3mm, no peridontal attachment loss and no radiographic evidence of periodontal bone loss)
Key exclusion criteria (6 listed)
- gingivitis/ periodontitis
- interproximal fillings
- missing teeth
- crowding or spacing in premolar or molar area
- severe systemic disease
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 laser therapyAlso: LLLTDiode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany) was applied to the RIGHT side. Laser was set at PDT mode (660nm) acupuncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer. The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered. The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators. | Device | Laser treated side, Placebo side |
Primary outcome
Assesment of pain
Time frame: 3 days
The pain was assessed with a visual analogue scale (VAS), which is a 100-mm-long hori-zontal line where one end corresponds to "no pain" and the other end indicates "worst pain possible." The participants filled out the questionnaire immediately after the placement of separators (TO) and before 1st laser treatment, 12 hours (T1), 24hours (T2) and just after 2nd laser treatment, 2 days (T3) and 3 days after the 1st treatment (T4) (Table 1). At each evalua-tion period, the degree of pain was scored twice, one for each side. Each patient was re-quired to indicate whether he/she had taken any analgesics during the recorded period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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.
Senka Mestrovic, DDS, PhD study director
University of Zagreb
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 therapy in people with Pain Relief Caused by Placing Orthodontic Separators, run by University Hospital Rijeka at 1 site in Croatia.
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 6 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 31 Aug 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 Croatia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assesment of pain (time frame: 3 days). 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 Aug 2020.