Malocclusion, Angle Class INCT03646942

The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients

A study testing low level laser therapy and Lingual Orthodontics in people with Malocclusion, Angle Class I and Crowding, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

We will treat patients with class I malocclusion who have moderate crowding (4-6 mm) according to Little's irregularity index and asses the efficacy of low level laser therapy in accelerating orthodontic tooth movement . There is two groups : 1. treated with Low level laser therapy (LLLT) 2. Read more about this study

Who is it for?: Ages 17 to 27 years
Conditions the study is for: Malocclusion, Angle Class I, Crowding
What is being tested?: low level laser therapy and Lingual Orthodontics
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSyria
Study dates: 15 Jun 2017to 1 Feb 2019
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 17 to 27 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Class I malocclusion with mild to moderate crowding
Old between 17-27 years
Good oral hygiene
Patients should be fit and well
4-6 mm crowding in upper incisors according to Little's index
Enough clinical crowns length

Who cannot join

Patients who had an old orthodontic treatment
People who have any drug or disease affect orthodontic movement
Any contraindication for orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontic Department, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of Low-Level-LASER Therapy (LLLT) Effect on Accelerating Orthodontic Tooth Movement For Crowded Upper Incisors Leveling and Alignment in Lingual Orthodontic Patients: A Randomized Clinical Controlled Trial

There is two groups :

treated with Low level laser therapy (LLLT)
treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed.

Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .

Read the detailed description

The time of orthodontic treatment is considered to be one of the most concerns for patients. The study will investigate the effect of low level laser therapy on the speed of orthodontic tooth movement during the correction of moderately crowded anterior upper teeth using lingual orthodontic appliance.

The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention.

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.

Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .

Conditions: Malocclusion, Angle Class I, Crowding
Being tested: low level laser therapy, Lingual Orthodontics
Medical subject headings: Malocclusion, Angle Class I, Crowding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low level laser therapyRadiation
Also called LLLT, soft tissue laser
low level laser therapy will be used in order to induce tooth movement. 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 Joules/each tooth.
Lingual OrthodonticsDevice
Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.

Study groups in NCT03646942
Study group	Role	What they receive
Lingual orthodontics	Active comparator	Patients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way. Receives: Radiation: low level laser therapy; Device: Lingual Orthodontics
Low level laser therapy	Experimental	Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces. Receives: Radiation: low level laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of tooth alignment
Days required to complete tooth alignment will be counted.
Measured: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
Change in Tooth Alignment at one month
Little's Index of Irregularity will be measured at 30 days after the onset of treatment.
This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.
Change in Tooth Alignment at two months
Little's Index of Irregularity will be measured at 60 days after the onset of treatment.
This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.
Change in Tooth Alignment at the end of Alignment Stage
Little's Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: T1: one day before the beginning of treatment; T2: when alignment of teeth is complete and this is expected to occur within 90 - 120 days

Secondary outcomes (2)

Change in the levels of pain and discomfort
Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment.
Measured: T1: 10 minutes following the insertion of the first wire in the beginning of treatment; T2: at 24 hours post-commencement; T3: at 48 hours; T4: at 72 hours following the placement of primary archwire
Change in Patients' Acceptance
Assessment will be performed using a standardized questionnaire
Measured: (1) one day following the beginning of the treatment, (2) after one week of the beginning of treatment, (3) after 4 weeks, (5) at the end the alignment stage which is expected to occur within 3 to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20171 Feb 2019

First posted24 Aug 2018
Study start15 Jun 2017
Primary completion1 Oct 2018
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Malocclusion, Angle Class IStudies 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03646942
Sponsor's protocol ID: UDDS-Ortho-08-2018
Status last verified: Jul 2019
First submitted: 22 Aug 2018
Last updated: 18 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.
PubMed 27869476
Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
PubMed 23075062
Fritz U, Diedrich P, Wiechmann D. Lingual technique--patients' characteristics, motivation and acceptance. Interpretation of a retrospective survey. J Orofac Orthop. 2002 May;63(3):227-33. doi: 10.1007/s00056-002-0124-3. English, German.
PubMed 12132310
Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.
PubMed 25072362
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 15334614
Camacho AD, Velasquez Cujar SA. Dental movement acceleration: Literature review by an alternative scientific evidence method. World J Methodol. 2014 Sep 26;4(3):151-62. doi: 10.5662/wjm.v4.i3.151. eCollection 2014 Sep 26.
PubMed 25332914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Low-Level-LASER Therapy (LLLT) Effect on Accelerating Orthodontic Tooth Movement For Crowded Upper Incisors Leveling and Alignment in Lingual Orthodontic Patients: A Randomized Clinical Controlled Trial
ClinicalTrials.gov ID: NCT03646942
Acronym / sponsor ID: UDDS-Ortho-08-2018
Conditions: Malocclusion, Angle Class I, Crowding
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Jun 2017 (actual)
Primary completion: 1 Oct 2018 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 24 Aug 2018 (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.

There is two groups :

treated with Low level laser therapy (LLLT)
treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed.

Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .

Detailed description

The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention.

Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lingual orthodontics	Active comparator	Radiation: low level laser therapy, Device: Lingual OrthodonticsPatients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way.
Low level laser therapy	Experimental	Radiation: low level laser therapyPatients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.

Who may qualify

Ages: 17 to 27 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Class I malocclusion with mild to moderate crowding
Old between 17-27 years
Good oral hygiene
Patients should be fit and well
4-6 mm crowding in upper incisors according to Little's index

Key exclusion criteria (3 listed)

Patients who had an old orthodontic treatment
People who have any drug or disease affect orthodontic movement
Any contraindication for orthodontic treatment

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: LLLT, soft tissue laserlow level laser therapy will be used in order to induce tooth movement. 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 Joules/each tooth.	Radiation	Lingual orthodontics, Low level laser therapy
Lingual OrthodonticsLingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.	Device	Lingual orthodontics

Primary outcome

Duration of tooth alignment
Time frame: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
Days required to complete tooth alignment will be counted.
Change in Tooth Alignment at one month
Time frame: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.
Little's Index of Irregularity will be measured at 30 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Change in Tooth Alignment at two months
Time frame: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.
Little's Index of Irregularity will be measured at 60 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Change in Tooth Alignment at the end of Alignment Stage
Time frame: T1: one day before the beginning of treatment; T2: when alignment of teeth is complete and this is expected to occur within 90 - 120 days
Little's Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.

2 secondary outcomes

Change in the levels of pain and discomfort
Time frame: T1: 10 minutes following the insertion of the first wire in the beginning of treatment; T2: at 24 hours post-commencement; T3: at 48 hours; T4: at 72 hours following the placement of primary archwire
Change in Patients' Acceptance
Time frame: (1) one day following the beginning of the treatment, (2) after one week of the beginning of treatment, (3) after 4 weeks, (5) at the end the alignment stage which is expected to occur within 3 to 4 months

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 18 Jul 2019.
Background: PubMed 27869476AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.
Background: PubMed 23075062Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
Background: PubMed 12132310Fritz U, Diedrich P, Wiechmann D. Lingual technique--patients' characteristics, motivation and acceptance. Interpretation of a retrospective survey. J Orofac Orthop. 2002 May;63(3):227-33. doi: 10.1007/s00056-002-0124-3. English, German.
Background: PubMed 25072362Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.
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 25332914Camacho AD, Velasquez Cujar SA. Dental movement acceleration: Literature review by an alternative scientific evidence method. World J Methodol. 2014 Sep 26;4(3):151-62. doi: 10.5662/wjm.v4.i3.151. eCollection 2014 Sep 26.
Individual participant dataSharing planned: No

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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 Y Hajeer, DDS MSc PhD study chair

Associate Professor of Orthodontics, University of Damascus Dental School, SYRIA

Wael Al-Rasheed Omer, DDS principal investigator

MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA

Wael Mahdi, DDS MSc PhD study director

Associate Professor of Periodontics, 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 and Lingual Orthodontics in people with Malocclusion, Angle Class I and Crowding, 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 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: finished, as of the sponsor's last update on 18 Jul 2019. 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?

Duration of tooth alignment (time frame: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average). The study lists 4 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 NCT03646942, which also lists 6 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 18 Jul 2019.