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

Primary Purpose

Malocclusion, Angle Class II, Division 1

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Low-Level Laser Therapy (LLLT)
Flapless Corticopunture
Control
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II, Division 1 focused on measuring Orthodontic Tooth Movement Acceleration

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dental Medicine, Damascus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low-Level Laser Therapy (LLLT)

Flapless Corticopuncture

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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.
Changes in the gingival indices
Assessment will be performed clinically using the WHO probe
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)
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).
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)

Full Information

First Posted
June 10, 2019
Last Updated
January 18, 2021
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03999307
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
June 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II, Division 1
Keywords
Orthodontic Tooth Movement Acceleration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Laser Therapy (LLLT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Flapless Corticopuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
Patients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application.
Intervention Type
Radiation
Intervention Name(s)
Low-Level Laser Therapy (LLLT)
Intervention Description
LLLT will be applied in this group
Intervention Type
Procedure
Intervention Name(s)
Flapless Corticopunture
Intervention Description
Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Typical orthodontic treatment with no LLLT or flapless corticopuncture
Primary Outcome Measure Information:
Title
Duration of en-masse retraction of the six maxillary anterior teeth
Description
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
Time Frame
The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months
Title
Rate of en-masse retraction of the six maxillary anterior teeth
Description
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.
Time Frame
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 Measure Information:
Title
Maxillary first molar anchorage loss
Description
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
Time Frame
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
Title
Root resorption
Description
Assessment will be performed by subtracting the root length of each maxillary anterior tooth after retraction from its length before starting retraction procedure.
Time Frame
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
Title
Changes in the gingival indices
Description
Assessment will be performed clinically using the WHO probe
Time Frame
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
Title
Change in tooth vitality (the response of the pulp tissue toward external stimuli)
Description
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)
Time Frame
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
Title
Changes in the levels of pain and discomfort
Description
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).
Time Frame
These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention
Title
Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.
Description
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)
Time Frame
The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Moaffak A. AlSayed Hasan, DDS, Msc Ortho, PhD Student
Organizational Affiliation
PhD Student, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mowaffak Ajaj, DDS, Msc Ortho, PhD
Organizational Affiliation
Assistant Professor, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Omar Hamadah, DDS, Msc, PhD
Organizational Affiliation
Assistant Professor, Department of Oral Medicine - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dental Medicine, Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27869476
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.
Results Reference
background
PubMed Identifier
23787192
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.
Results Reference
background
PubMed Identifier
22381489
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.
Results Reference
background
PubMed Identifier
24680025
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.
Results Reference
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PubMed Identifier
28402521
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.
Results Reference
background
PubMed Identifier
27696311
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.
Results Reference
result
PubMed Identifier
24182579
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.
Results Reference
result

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

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