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

NCT ID: NCT03999307

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2020-11-06

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.

Conditions

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Malocclusion, Angle Class II, Division 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-Level Laser Therapy (LLLT)

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.

Group Type EXPERIMENTAL

Low-Level Laser Therapy (LLLT)

Intervention Type RADIATION

LLLT will be applied in this group

Flapless Corticopuncture

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.

Group Type EXPERIMENTAL

Flapless Corticopunture

Intervention Type PROCEDURE

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

Control

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

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

Typical orthodontic treatment with no LLLT or flapless corticopuncture

Interventions

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Low-Level Laser Therapy (LLLT)

LLLT will be applied in this group

Intervention Type RADIATION

Flapless Corticopunture

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

Intervention Type PROCEDURE

Control

Typical orthodontic treatment with no LLLT or flapless corticopuncture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Mowaffak Ajaj, DDS, Msc Ortho, PhD

Role: STUDY_CHAIR

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

Omar Hamadah, DDS, Msc, PhD

Role: STUDY_CHAIR

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

Locations

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Faculty of Dental Medicine, Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 27869476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23787192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22381489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24680025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28402521 (View on PubMed)

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.

Reference Type RESULT
PMID: 27696311 (View on PubMed)

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.

Reference Type RESULT
PMID: 24182579 (View on PubMed)

Other Identifiers

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UDDS-Ortho-04-2020

Identifier Type: -

Identifier Source: org_study_id

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