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

NCT03999307 | Completed

• 1 other identifier: UDDS-Ortho-04-2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II, Division 1

Keywords

Orthodontic Tooth Movement Acceleration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Maxillary first molar anchorage loss

  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

  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

  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)

  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

  These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention

Study Arms (3)

Low-Level Laser Therapy (LLLT)

EXPERIMENTAL

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)

Flapless Corticopuncture

EXPERIMENTAL

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

Control

EXPERIMENTAL

Patients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application.

Other: Control

Interventions

Low-Level Laser Therapy (LLLT) RADIATION

LLLT will be applied in this group

Low-Level Laser Therapy (LLLT)

Flapless Corticopunture PROCEDURE

Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur

Flapless Corticopuncture

Control OTHER

Typical orthodontic treatment with no LLLT or flapless corticopuncture

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Faculty of Dental Medicine, Damascus University

Damascus, Syria

Location

Related Publications (7)

• 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.

  PMID: 27869476 BACKGROUND

• 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.

  PMID: 23787192 BACKGROUND

• 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.

  PMID: 22381489 BACKGROUND

• 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.

  PMID: 24680025 BACKGROUND

• 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.

  PMID: 28402521 BACKGROUND

• 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.

  PMID: 27696311 RESULT

• 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.

  PMID: 24182579 RESULT

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohammad Moaffak A. AlSayed Hasan, DDS, Msc Ortho, PhD Student

  PhD Student, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic

  PRINCIPAL INVESTIGATOR

• Mowaffak Ajaj, DDS, Msc Ortho, PhD

  Assistant Professor, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic

  STUDY CHAIR

• Omar Hamadah, DDS, Msc, PhD

  Assistant Professor, Department of Oral Medicine - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 26, 2019
• Study Start: August 6, 2018
• Primary Completion: June 6, 2020
• Study Completion: November 6, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)