An interventional study of low level laser therapy and Lingual Orthodontics in Malocclusion, Angle Class I and Crowding, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 17 Years to 27 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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 :
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 .
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 .
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 36 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: low level laser therapy · Device: Lingual Orthodontics
Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.
Radiation: low level laser therapy
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.
Also known as: LLLT, soft tissue laser
Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.
Duration of tooth alignment
Days required to complete tooth alignment will be counted.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
Assessment will be performed using a standardized questionnaire
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
Plan to share: No
Ran from Jun 2017 to primary completion in Oct 2018, 15 months.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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