Maxillary Crowded TeethNCT02568436
Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases
A study testing low level laser therapy in people with Maxillary Crowded Teeth, run by Damascus University at 1 site in Syria.
Trial summary
26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each… Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Maxillary Crowded Teeth
- What is being tested?
- low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSyria
- Study dates
- Jul 2015to May 2016
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between (16 - 24) years.
- Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars.
- All upper teeth are existed (except for third molars).
- Patients have not undergone previous orthodontic treatment.
- Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
- Patient with good oral hygiene (Plaque Index less than 1).
Who cannot join
- Any medical condition affecting orthodontic tooth movement.
- Bad oral hygiene (Plaque Index greater than 1).
- Any peri-apical lesions developed during treatment.
- Patient lack of commitment toward follow-up appointments.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
Official title: Evaluation of Low-Level Laser Therapy (LLLT) Effectiveness in Accelerating Orthodontic Tooth Movement For Dental Crowding Cases: A Randomized Controlled Clinial Trial
26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth. Control group will undergo typical orthodontic treatment with the laser device applied the same manner but without being turned on (to get the placebo effect for pain reduction effect). This procedure will be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the end of the leveling and alignment stage.
Read the detailed description
The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment.
Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption.
A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.
- Conditions
- Maxillary Crowded Teeth
- 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 therapyRadiation
low level laser therapy is intended to accelerate tooth movement
| Study group | Role | What they receive |
|---|---|---|
| Conventional Decrowding | No intervention | Crowded upper incisors will be treated in the conventional manner with a fake irradiation without using low level laser therapy. |
| Low Level Laser Therapy | Experimental | Each maxillary incisor will be subjected to low level laser therapy at specific times in order to accelerate tooth movement Receives: Radiation: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Leveling and Alignment Time (OLAT)
As mentioned above
Measured: This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.
Change in Leveling and Alignment Improvement Percentage (LAIP)
LAIP will be measured by dividing the amount of change in LII value at a specific time intervals (i.e. T3-T0, T2-T0, T1-T0; calculated by subtracting LII value at T1, T2 and T3 from LII value at (T0) by LII value at T0 (i.e. the beginning of treatment).
Measured: this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII)
Secondary outcomes (1)
Change of levels of pain
Using a visual analog scale, each patient will indicate the severity of his/her perceived pain.
Measured: Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maxillary Crowded TeethStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Moaffak Al-Sayed Hasan, DDS, Principal investigator, MSc student at the Orthodontic Department, University of Damascus Dental SchoolKinda Sultan, DDS MSc PhD, Study director, Senior Lecturer in Orthodontics, University of Damascus Dental School, SYRIAOmar Hamadah, DDS MSc PhD, Study director, Senior Lecturer, Oral Medicine Department, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568436
- Sponsor's protocol ID
- UDDS-Ortho-02-2015
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
PubMed 15334614Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
PubMed 22381489Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.
PubMed 24984620Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
PubMed 24326198Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
PubMed 23153291Tortamano A, Lenzi DC, Haddad AC, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2009 Nov;136(5):662-7. doi: 10.1016/j.ajodo.2008.06.028.
PubMed 19892282AlSayed Hasan MMA, Sultan K, Ajaj M, Voborna I, Hamadah O. Low-level laser therapy effectiveness in reducing initial orthodontic archwire placement pain in premolars extraction cases: a single-blind, placebo-controlled, randomized clinical trial. BMC Oral Health. 2020 Jul 20;20(1):209. doi: 10.1186/s12903-020-01191-7.
PubMed 32690001
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Laser Therapy (LLLT) Effectiveness in Accelerating Orthodontic Tooth Movement For Dental Crowding Cases: A Randomized Controlled Clinial Trial
- ClinicalTrials.gov ID
- NCT02568436
- Acronym / sponsor ID
- UDDS-Ortho-02-2015
- Conditions
- Maxillary Crowded Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Oct 2015 (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.
26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth. Control group will undergo typical orthodontic treatment with the laser device applied the same manner but without being turned on (to get the placebo effect for pain reduction effect). This procedure will be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the end of the leveling and alignment stage.
Detailed description
The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment.
Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption.
A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Decrowding | No intervention | –Crowded upper incisors will be treated in the conventional manner with a fake irradiation without using low level laser therapy. |
| Low Level Laser Therapy | Experimental | Radiation: low level laser therapyEach maxillary incisor will be subjected to low level laser therapy at specific times in order to accelerate tooth movement |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged between (16 - 24) years.
- Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars.
- All upper teeth are existed (except for third molars).
- Patients have not undergone previous orthodontic treatment.
- Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
Key exclusion criteria (4 listed)
- Any medical condition affecting orthodontic tooth movement.
- Bad oral hygiene (Plaque Index greater than 1).
- Any peri-apical lesions developed during treatment.
- Patient lack of commitment toward follow-up appointments.
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 therapylow level laser therapy is intended to accelerate tooth movement | Radiation | Low Level Laser Therapy |
Primary outcome
Overall Leveling and Alignment Time (OLAT)
Time frame: This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.
As mentioned above
Change in Leveling and Alignment Improvement Percentage (LAIP)
Time frame: this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII)
LAIP will be measured by dividing the amount of change in LII value at a specific time intervals (i.e. T3-T0, T2-T0, T1-T0; calculated by subtracting LII value at T1, T2 and T3 from LII value at (T0) by LII value at T0 (i.e. the beginning of treatment).
1 secondary outcome
Change of levels of pain
Time frame: Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up.
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 11 Jul 2016.
- Background: PubMed 15334614Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
- Background: PubMed 22381489Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
- Background: PubMed 24984620Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.
- Background: PubMed 24326198Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
- Background: PubMed 23153291Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
- Background: PubMed 19892282Tortamano A, Lenzi DC, Haddad AC, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2009 Nov;136(5):662-7. doi: 10.1016/j.ajodo.2008.06.028.
- Derived from this study: PubMed 32690001AlSayed Hasan MMA, Sultan K, Ajaj M, Voborna I, Hamadah O. Low-level laser therapy effectiveness in reducing initial orthodontic archwire placement pain in premolars extraction cases: a single-blind, placebo-controlled, randomized clinical trial. BMC Oral Health. 2020 Jul 20;20(1):209. doi: 10.1186/s12903-020-01191-7.
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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 Moaffak Al-Sayed Hasan, DDS principal investigator
MSc student at the Orthodontic Department, University of Damascus Dental School
Kinda Sultan, DDS MSc PhD study director
Senior Lecturer in Orthodontics, University of Damascus Dental School, SYRIA
Omar Hamadah, DDS MSc PhD study director
Senior Lecturer, Oral Medicine Department, University of Damascus Dental School, Damascus, Syria
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 Maxillary Crowded Teeth, run by Damascus University at 1 site in Syria.
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 4 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 11 Jul 2016. 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 Syria. 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 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?
Overall Leveling and Alignment Time (OLAT) (time frame: This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.). 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?
On the ClinicalTrials.gov record for NCT02568436, which also lists 7 linked publications.
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 11 Jul 2016.