Which is Better Piezosurgery or Piezosurgery With Laser in Accelerating Orthodontic Tooth Movement

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05655169
Collaborator
(none)
60
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3
26.4
2.3

Study Details

Study Description

Brief Summary

Sixty patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary anterior teeth will be divided randomly into three groups: piezocision group, piezocision with low-level laser therapy group, and control group. In each group, after the levelling and alignment phase is completed, the rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after two weeks, the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side. For anchorage, mini implants will be inserted between the second premolars and the first molar on each side.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Piezosurgery and GaALAs diode laser
  • Procedure: Piezosurgery
  • Other: Fixed orthodontic appliance
N/A

Detailed Description

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 six weeks of piezosurgery, a 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 two halves; gingival and cervical, and the laser will be applied in the center of each half from both buccal and palatal sides which means four application points and total energy of 16 Joules per tooth. LLLT irradiation will be performed in the sixth week after the onset of mass retraction (day 0). After that, irradiation is repeated on days 3, 7, and 14, then every two weeks, until the class I canine relationship is achieved and/or spaces lateral to incisors are closed

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Piezocision or the Combination of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During En-masse Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Trial
Actual Study Start Date :
Oct 9, 2019
Actual Primary Completion Date :
Jan 12, 2021
Actual Study Completion Date :
Dec 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Piezosurgery and low-level laser therapy

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

Procedure: Piezosurgery and GaALAs diode laser
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. After six weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 seconds per point will be applied.

Experimental: Piezosurgery only

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

Procedure: Piezosurgery
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.

Active Comparator: Traditional treatment without acceleration

In this group of patients, the en masse retraction will be conventional without any acceleration intervention.

Other: Fixed orthodontic appliance
After the levelling and alignment phase is completed, the rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after two weeks, the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side.

Outcome Measures

Primary Outcome Measures

  1. The rate of en-masse retraction of upper anterior teeth [This will be assessed at the end of the active treatment, which is expected to occur within five months]

    The rate of en-masse retraction of upper anterior teeth (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the upper central incisor edge to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the canine apex and third palatal rugae projections. Measuring the distance (mm) between the central incisor edge and third palatal rugae projections. The rate of en-masse retraction will be measured by dividing the distance between the canine apex/central incisor edge projections and the third palatal rugae projection by the time elapsed between assessment times.

  2. Change in the anteroposterior movement of the molar [Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase]

    The anteroposterior movement of the molar (mm/month) in each group will be calculated. This outcome will be measured on the dental casts by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The anteroposterior movement of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.

  3. Change in the inter-canine width [Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase]

    The change in the inter-canine width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the cusp tips of the two upper canines. This variable will be measured on dental casts.

  4. Change in the inter-molar width at 5 months [Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase]

    The change in the inter-molar width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the central groove of the two first maxillary molars. This variable will be measured on dental casts.

Secondary Outcome Measures

  1. Change in molar antero-posterior position [Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase]

    The amount of distance being travelled by the first molars is going to be measured on study models taken at monthly intervals until the end of the retraction phase.

  2. Amount of canine rotation [Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase]

    The amount of the rotation of canine is going to be measured on study models taken at monthly intervals until the end of the retraction phase.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 28 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Permanent occlusion.

  2. Existence of all the upper teeth (except third molars).

  3. 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

  1. The patient had previous orthodontic treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Damascus Damascus Syrian Arab Republic

Sponsors and Collaborators

  • Damascus University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT05655169
Other Study ID Numbers:
  • UDDS-Ortho-14-2022
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022