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

NCT06639204 | Completed DMC

• 1 other identifier: UDDS-Ortho-5-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (18)

• Duration of the en-masse retraction of anterior teeth

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

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

• Change in the SNA angle

  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.

  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)

• Change in the SNB angle

  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.

  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)

• Change in the ANB angle

  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.

  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)

• Change in the SNPog angle

  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.

  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)

• Change in the SN-GoMe angle

  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.

  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)

• Change in the MM angle

  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.

  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)

• Change in the Bjork's sum

  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.

  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)

• Change in Y-axis angle

  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.

  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)

• Change in the SN-U1

  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

  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)

• Change in the GoMe-L1 angle

  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.

  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)

• Change in the IIA angle

  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.

  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)

• Change in the SV-U1E distance

  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.

  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)

• Change in the SV-U1A distance

  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.

  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)

• Change in the Nasolabial angle

  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.

  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)

• Change in the labiomental angle

  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.

  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)

• Change in the UL-E Line distance

  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.

  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)

• Change in the LL-E Line distance

  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.

  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)

Study Arms (2)

Electrical Stimulation

EXPERIMENTAL

Electric current will be applied in this group of patients using a removable device.

Device: Electrical stimulation

Conventional treatment with no stimulation

ACTIVE COMPARATOR

No acceleration method will be performed in this group

Procedure: Orthodontic treatment without acceleration

Interventions

Electrical stimulation DEVICE

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

Electrical Stimulation

Orthodontic treatment without acceleration PROCEDURE

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

Conventional treatment with no stimulation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, Syria

Location

Related Publications (4)

• Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.

  PMID: 26917494 BACKGROUND

• Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.

  PMID: 6243448 BACKGROUND

• Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.

  PMID: 37234453 BACKGROUND

• Shaadouh RI, Hajeer MY, Alam MK, Sultan K, Aljabban O. Evaluation of the skeletal, dental, and soft-tissue changes after the en-masse retraction of upper anterior teeth stimulated by low-intensity electrical current: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):902. doi: 10.1186/s12903-025-06316-4.

  PMID: 40462109 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Electric Stimulation; Orthodontics; Acceleration

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Dentistry; Motion; Physical Phenomena

Study Officials

• Mohammad Younis Hajeer, DDS MSc PhD

  Orthodontics Department, Faculty of Dentistry, University of Damascus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: May 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 1, 2023
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)