Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction

Study Overview
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Brief Summary
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The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.

Detailed Description
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This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.

Official Title
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Evaluation of Low-Level Laser Therapy (LLLT) and Flapless Corticopuncture Effect on Accelerating Implant-Supported En-Masse Retraction of the Six Maxillary Anterior Teeth (Clinical Randomized Controlled Trial)

Conditions
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Malocclusion, Angle Class II, Division 1

Intervention / Treatment
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* Radiation: Low-Level Laser Therapy (LLLT)
* Procedure: Flapless Corticopunture
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age between (18 - 24) years. Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters: ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical. All upper teeth are existed (Except for third molars). Mild to moderate crowding (3 mm or less). Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …). Good oral hygiene (Plaque index < 1). Exclusion Criteria: Any medical condition affecting orthodontic tooth movement. Poor oral hygiene (Plaque index > 1). Patient did not undergo previous orthodontic treatment. Patient lack of commitment toward follow-up appointments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Level Laser Therapy (LLLT)<br>In the LLLT group, a low-level laser with wavelength of 808 nm, output of 250 mW, energy of 4 Joules per point and application time of 16 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into 2 halves; gingival and cervical, and laser will be applied in the center of each half from both buccal and palatal sides which means 4 application points and a total energy of 16 Joules per tooth. | Radiation: Low-Level Laser Therapy (LLLT)<br>* LLLT will be applied in this group<br>|
| Experimental: Flapless Corticopuncture<br>In the flapless corticopuncture group, 3 interdental punctures located between the roots of the six maxillary anterior teeth from both the buccal and palatal sides, will be done using a 1-mm diameter round surgical Tungsten bur with 1 mm depth and 1.5 mm space between each puncture. These punctures start 2 mm from the free gingiva. Besides, an additional 2 parallel set of punctures with the same dimensions of the interdental ones will be done in the extraction sockets from both the buccal and palatal sides. | Procedure: Flapless Corticopunture<br>* Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur<br>|
| Experimental: Control<br>Patients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application. | Other: Control<br>* Typical orthodontic treatment with no LLLT or flapless corticopuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of en-masse retraction of the six maxillary anterior teeth | Assessment will be performed by calculating the time required from the beginning of the six maxillary anterior teeth retraction till the completion of this procedure | The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months | 
| Rate of en-masse retraction of the six maxillary anterior teeth | Assessment will be performed on study models by dividing the distance that the six maxillary anterior teeth moved during retraction to the time required to retract them to their ideal positions. | The calculation of the rate of retraction will be done once the retraction procedure has finished which is expected to occur within four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillary first molar anchorage loss | Assessment will be performed on study casts by calculating the amount of mesial drifting of the maxillary molar (if any) in millimeters before and after retraction | This outcome will be measured one day before upper incisors' retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months | 
| Root resorption | Assessment will be performed by subtracting the root length of each maxillary anterior tooth after retraction from its length before starting retraction procedure. | A CBCT image will be taken one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months | 
| Changes in the gingival indices | Assessment will be performed clinically using the WHO probe | This outcome will be measured one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months | 
| Change in tooth vitality (the response of the pulp tissue toward external stimuli) | Tooth vitality will be evaluated for each tooth of the six maxillary anterior teeth using Ethyl Chloride applied by a cotton roll on each tooth, which will indicate negative response (no vitality) or positive response (vital pulp) | This outcome will be measured one day before the six maxillary anterior teeth retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months | 
| Changes in the levels of pain and discomfort | Assessment will be performed using questionnaires that include Visual Analog Scale (VAS) for each question, the scale has a minimum scale of 0 (no pain or discomfort) and a maximum scale of 100 (maximum pain or discomfort). | These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention | 
| Change in the Oral Health Related Quality of Life associated with anterior teeth retraction. | Assessment will be performed using the OHIP-14 questionnaire; which is a questionnaire that include 14 questions regarding different aspects of problems that might be associated with retraction (discomfort, stress, chewing difficulties, ...). the patient could choose the answer from a five-point Likert scale (Never, Hardly ever, Occasionally, Fairly often, Very often) | The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic Tooth Movement Acceleration