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Completed

NCT Number: NCT06639204

Cephalometric Changes Following Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Current

Thirty-six patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be randomly assigned into two groups: low-intensity electrical stimulation group (LIES) and traditional retraction group (TRAD) after the leveling and alignment phase is completed. En-masse retraction will be initiated in both groups via closed nickel-titanium coil springs that applying 250 g of force on each side, Mini-implants will be inserted to provide the highest level of anchorage. The skeletal, dental, and soft tissue changes will be detected using lateral cephalometric radiographs, which will be obtained pretreatment, pre-, and post-en-masse retraction of the anterior teeth.

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Key information

Conditions

Class II Division 1 Malocclusion Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, Syria

About this study

All candidate patients will be examined to determine the orthodontic treatment plan. Written informed consent will be obtained from all patients who accept to participate in the trial. Self-drilling mini-screws (1.6mm diameter and 8mm length) will be used to provide anchorage. They will be inserted bilaterally 8-10 mm above the level of the interdental papilla, between the second premolars and the first molar. Then, the maxillary first premolar will be extracted. Leveling and alignment of the upper dental arch will be done using a pre-adjusted orthodontic appliance: MBT™, 0.022 × 0.028-inch slots-size brackets. The removable electrical stimulation device utilized in the Shaadouh et al. study to provide the electrical stimulation will be used in this trial for the same purpose. Each patient in the low-intensity electrical stimulation group will be asked to wear a removable device for five hours daily until the completion of the retraction of the upper anterior teeth.

The en-masse retraction will be done by applying 250 g force on each side using two NiTi springs attached between the mini-implants and the crimpable hooks in a direction approximately parallel to the occlusal plane. The force will be calibrated every two weeks. The en-masse retraction will continue until a class I canine relationship and a correct incisor relationship, which will consider the endpoint of this phase.

Lateral cephalometric radiographs will be obtained pretreatment, pre-, and post-en-masse retraction of the anterior teeth to assess the skeletal, dental, and soft tissue changes. The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult healthy patients, Male and female, Aged 18-25 years.
  • Class II Division 1 malocclusion :
  • Mild/moderate skeletal Class II (ANB= 5-7 degrees)
  • 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 (corticosteroids, 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

  • Patient had previous orthodontic treatment

Treatment and study plan

Electrical Stimulation

Device

A removable appliance will be used to accelerate orthodontic tooth movement by emitting electrical stimulation.

Orthodontic treatment without acceleration

Procedure

No additional appliances will be used. Only the traditional fixed appliances (braces).

Primary outcomes

  1. Duration of the en-masse retraction of anterior teeth

    Time frame: At the end of en-masse retraction which is expected to occur within 6-10 months.

    Assessment will be performed by calculating the time required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.

  2. Change in the SNA angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  3. Change in the SNB angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  4. Change in the ANB angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  5. Change in the SNPog angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  6. Change in the SN-GoMe angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the position of the lower jaw in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  7. Change in the MM angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  8. Change in the Bjork's sum

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the amount of vertical divergence in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  9. Change in Y-axis angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the amount of vertical divergence in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  10. Change in the SN-U1

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees

  11. Change in the GoMe-L1 angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship of the lower anterior teeth with the mandibular plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  12. Change in the IIA angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship of the upper and lower anterior teeth in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees.

  13. Change in the SV-U1E distance

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This measurement represents the distance of the incisal edge of the maxillary incisors from the reference plane SV. Lateral cephalograms will be taken, and this measurement will be in millimeters.

  14. Change in the SV-U1A distance

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This measurement represents the distance of the apex of the maxillary incisors from the reference plane SV. Lateral cephalograms will be taken, and this measurement will be in millimeters.

  15. Change in the Nasolabial angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship of the upper lip with the nose in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  16. Change in the labiomental angle

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This angle represents the relationship of the lower lip with the chin in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.

  17. Change in the UL-E Line distance

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This measurement represents the relationship between the upper lip and the Ricketts line in cephalometric analysis. Lateral cephalograms will be taken, and this variable will be measured in mm.

  18. Change in the LL-E Line distance

    Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)

    This measurement represents the relationship between the Lower lip and the Ricketts line in cephalometric analysis. Lateral cephalograms will be taken, and this variable will be measured in mm.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Skeletal, Dental and Soft-tissue Changes After En-masse Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Current: A Single-centered, Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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