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Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Piezocision+GaALAs diode laser
Piezocision
Orthodontic fixed appliance
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion

Eligibility Criteria

17 Years - 28 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult healthy patients, Male and female, Age range: 17-28 years. Class II Division 1 malocclusion : Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) Mild to moderate crowding ≤ 4 Permanent occlusion. Existence of all the upper teeth (except third molars). Good oral and periodontal health: Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …) Presence of primary teeth in the maxillary arch Missing permanent maxillary teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 The patient had previous orthodontic treatment

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Piezosurgery pulse Low-level laser therapy

Piezosurgery

Traditional treatment

Arm Description

Piezocision will be applied in this group of patients using a piezosurgery knife and after 6 weeks of initial retraction, low-level laser therapy will be applied in this group of patients using a diode laser device.

Piezocision will be applied in this group of patients using a piezosurgery knife.

En masse retraction in this group will be performed in a conventional method.

Outcomes

Primary Outcome Measures

Change in the levels of pain during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of pain during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of discomfort during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of discomfort during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of swelling during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of swelling during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of eating difficulty during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of eating difficulty during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of satisfaction assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Recommendation of the procedure to a friend
Patients are asked if they would recommend the procedure to a friend. This question is going to be answered by "Yes" or "No", i.e., dichotomous scale.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
September 27, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05656898
Brief Title
Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction
Official Title
Comparison Between the Flapless Corticotomy Enhanced by the Later Application of Low-intensity Laser Therapy on Patient-centred Outcomes and Periodontal Health in Patients Undergoing en Masse Retraction of Upper Anterior Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
May 15, 2023 (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
Yes

5. Study Description

Brief Summary
60 patients will be treated by extraction of maxillary first premolars by applying mini-screws between the maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). They will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.
Detailed Description
Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth. The en-masse retraction will be obtained with two nickel-titanium coil springs placed between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane, a force of 250 g will be applied on each side to perform en-masse retraction. The retraction will be stopped when a Class I canine relation is achieved and a good incisor relation is obtained or spaces lateral to canines are closed. Regarding the Piezocision, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8 mm in length. No suturing will be needed. Regarding the piezocision with the later application of low-level laser therapy (LLLT): After seven weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 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 the laser will be applied in the centre of each half from both buccal and palatal sides which means 4 application points and total energy of 16 Joules per tooth. The LLLT will be applied 5 times in the first month of en masse retraction. After that, the irradiation will be repeated every two weeks, until the class, I canine relationship will be achieved and/or spaces lateral to incisors were closed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Piezosurgery pulse Low-level laser therapy
Arm Type
Experimental
Arm Description
Piezocision will be applied in this group of patients using a piezosurgery knife and after 6 weeks of initial retraction, low-level laser therapy will be applied in this group of patients using a diode laser device.
Arm Title
Piezosurgery
Arm Type
Experimental
Arm Description
Piezocision will be applied in this group of patients using a piezosurgery knife.
Arm Title
Traditional treatment
Arm Type
Active Comparator
Arm Description
En masse retraction in this group will be performed in a conventional method.
Intervention Type
Device
Intervention Name(s)
Piezocision+GaALAs diode laser
Intervention Description
After seven weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth .
Intervention Type
Device
Intervention Name(s)
Piezocision
Intervention Description
Vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.
Intervention Type
Device
Intervention Name(s)
Orthodontic fixed appliance
Intervention Description
Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.
Primary Outcome Measure Information:
Title
Change in the levels of pain during the first month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of pain during the third month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of discomfort during the first month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of discomfort during the third month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of swelling during the first month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of swelling during the third month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of eating difficulty during the first month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of eating difficulty during the third month of treatment assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Title
Change in the levels of satisfaction assessed by the VAS
Description
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Time Frame
These levels will be assessed only at day 14 of month 3 following the commencement of the retraction.
Title
Recommendation of the procedure to a friend
Description
Patients are asked if they would recommend the procedure to a friend. This question is going to be answered by "Yes" or "No", i.e., dichotomous scale.
Time Frame
This question is going to be posed only at day 14 of month 3 following the commencement of the retraction.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients, Male and female, Age range: 17-28 years. Class II Division 1 malocclusion : Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) Mild to moderate crowding ≤ 4 Permanent occlusion. Existence of all the upper teeth (except third molars). Good oral and periodontal health: Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …) Presence of primary teeth in the maxillary arch Missing permanent maxillary teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 The patient had previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mudar Mohammad Mousa, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32909702
Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
Results Reference
background
PubMed Identifier
35796046
Citation
Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.
Results Reference
background
PubMed Identifier
27129491
Citation
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Results Reference
background
PubMed Identifier
24326120
Citation
Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
Results Reference
background
PubMed Identifier
30991984
Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Results Reference
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Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction

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