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

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

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: Piezocision+GaALAs diode laser; Device: Piezocision; Device: Orthodontic fixed appliance

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Y. Hajeer, DDS,MSc,PhD; Phone Number: +963940404840; Email: myhajeer@gmail.com

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • University of Damascus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult healthy patients, Male and female, Age range: 17-28 years.

2. 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
3. Permanent occlusion.
4. Existence of all the upper teeth (except third molars).

5. Good oral and periodontal health:

   • Probing depth < 4 mm
   • No radiographic evidence of bone loss.
   • Gingival index ≤ 1
   • Plaque index ≤ 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
2. Presence of primary teeth in the maxillary arch
3. Missing permanent maxillary teeth (except third molars).

4. Poor oral hygiene or Current periodontal disease:

   • Probing depth ≥ 4 mm
   • radiographic evidence of bone loss
   • Gingival index > 1
   • Plaque index > 1
5. The patient had previous orthodontic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezosurgery; Piezocision will be applied in this group of patients using a piezosurgery knife.	Device: 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.
Experimental: Piezosurgery pulse Low-level laser therapy; 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.	Device: Piezocision+GaALAs diode laser; 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 .
Active Comparator: Traditional treatment; En masse retraction in this group will be performed in a conventional method.	Device: Orthodontic fixed appliance; Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.
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).	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.
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).	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.
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).	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.
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).	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.
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).	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.
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).	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.
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).	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.
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).	These levels will be assessed only at day 14 of month 3 following the commencement of the retraction.
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.	This question is going to be posed only at day 14 of month 3 following the commencement of the retraction.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the plaque index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess oral hygiene status in enrolled patients. A. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth. C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket. D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.	Time 0: immediately before applying the fixed appliance; Time 1: Day 1 before the commencement of the retraction phase; Time 2: at the end of the retraction phase
The change in the gingival index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor colour change, slight oedema. No bleeding on probing. C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing. D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding.	Time 0: immediately before applying the fixed appliance; Time 1: Day 1 before the commencement of the retraction phase; Time 2: at the end of the retraction phase
The change in the bleeding index	Assessment will be achieved using a gingival probe according to Muhlemann (1977) to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears. D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse	Time 0: immediately before applying the fixed appliance; Time 1: Day 1 before the commencement of the retraction phase; Time 2: at the end of the retraction phase

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Mohammad Y. Hajeer, DDS,MSc,PhD, Department of orthodontics, Damascus University, Syria; Principal Investigator: Mudar Mohammad Mousa, DDS, Department of orthodontics, Damascus University, Syria

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: UDDS-Ortho-16-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No