Clinical trial NCT03999307: Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II, Division 1
Keywords: Orthodontic Tooth Movement Acceleration
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patient age between (18 - 24) years.
2. 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.
3. All upper teeth are existed (Except for third molars).
4. Mild to moderate crowding (3 mm or less).
5. Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, ...).
6. Good oral hygiene (Plaque index \< 1).

Exclusion Criteria:

1. Any medical condition affecting orthodontic tooth movement.
2. Poor oral hygiene (Plaque index \> 1).
3. Patient did not undergo previous orthodontic treatment.
4. Patient lack of commitment toward follow-up appointments.

Primary outcomes:
measure: Duration of en-masse retraction of the six maxillary anterior teeth
timeFrame: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months
measure: Rate of en-masse retraction of the six maxillary anterior teeth
timeFrame: 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 outcomes:
measure: Maxillary first molar anchorage loss
timeFrame: 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
measure: Root resorption
timeFrame: 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
measure: Changes in the gingival indices
timeFrame: 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
measure: Change in tooth vitality (the response of the pulp tissue toward external stimuli)
timeFrame: 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
measure: Changes in the levels of pain and discomfort
timeFrame: These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention
measure: Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.
timeFrame: The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Faculty of Dental Medicine, Damascus University
Study officials:
affiliation: PhD Student, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
name: Mohammad Moaffak A. AlSayed Hasan, DDS, Msc Ortho, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
name: Mowaffak Ajaj, DDS, Msc Ortho, PhD
role: STUDY_CHAIR
affiliation: Assistant Professor, Department of Oral Medicine - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
name: Omar Hamadah, DDS, Msc, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
citation: Doshi-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.
citation: Hoogeveen EJ, Jansma J, Ren Y. Surgically facilitated orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S51-64. doi: 10.1016/j.ajodo.2013.11.019.
citation: Tuncer NI, Arman-Ozcirpici A, Oduncuoglu BF, Gocmen JS, Kantarci A. Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial. Eur J Orthod. 2017 Nov 30;39(6):586-594. doi: 10.1093/ejo/cjx015.
citation: Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
citation: Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.