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

Malocclusion, Angle Class II, Division 1 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999307
• Other study ID #: UDDS-Ortho-04-2020
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: November 6, 2020

Study information

• Verified date: January 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 6, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II
• Malocclusion, Angle Class II, Division 1

Intervention

Radiation:
• Low-Level Laser Therapy (LLLT)
LLLT will be applied in this group

Procedure:
• Flapless Corticopunture
Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur

Other:
• Control
Typical orthodontic treatment with no LLLT or flapless corticopuncture

Locations

Country	Name	City	State
Syrian Arab Republic	Faculty of Dental Medicine, Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. — View 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. Epub 2016 Oct 24. Review. — View 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 — View 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. Erratum in: Angle Orthod. 2018 Jan;88(1):125. — View 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. — View 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. Review. — View Citation

Tunçer NI, Arman-Özçirpici A, Oduncuoglu BF, Göçmen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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