Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05302076
Collaborator
(none)
32
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2
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Study Details

Study Description

Brief Summary

Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be divided randomly into two groups: electrical group and control group. In each group, en-masse retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 250 g of force per side, Mini-implants will be used as an anchor unit.

The overall retraction duration will be calculated. The skeletal, dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth.

Condition or Disease Intervention/Treatment Phase
  • Device: Low-intensity electrical current (LIEC)
  • Device: Traditional fixed orthodontic appliance
N/A

Detailed Description

Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.

Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted.

A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current.

Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.

(250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks. Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained.

The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination.

Panoramic and 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.

Periodontal health will be assessed at the beginning of orthodontic treatment, before and after en-masse retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, probing depth and gingival recession.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation the Effect of Low-intensity Electrical Current (LIEC) in Accelerating the En-masse Retraction of the Maxillary Anterior Teeth and the Associated Skeletal, Dental and Periodontal Changes : A Randomized Controlled Clinical Trial
Actual Study Start Date :
Aug 23, 2019
Actual Primary Completion Date :
Feb 12, 2021
Actual Study Completion Date :
Dec 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: electric current

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

Device: Low-intensity electrical current (LIEC)
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.

Active Comparator: Traditional treatment

No acceleration method will be performed in this group.

Device: Traditional fixed orthodontic appliance
The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted. (250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction.

Outcome Measures

Primary Outcome Measures

  1. Duration of en-masse retraction of anterior teeth [The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.]

    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 SN-U1 angle [: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

    This angle the 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.

  3. Change in the SNA angle [: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

    This angle the 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.

  4. Change in the MM angle [: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

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

Secondary Outcome Measures

  1. Change in the Nasolabial angle [: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

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

  2. Change in the Li-E Line [: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.]

    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.

  3. Change in Root Length [This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    The root length will be measured for each root of six upper anterior teeth using panorama imaging, the change will be calculated between before and after images in mm.

  4. Change in the Plaque index [This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    The plaque index will be used to assess the status of the oral hygiene in these patients.

  5. Change in the Gingival Index [This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    The Gingival index will be used to assess the status of the gingival tissues around the teeth.

  6. Change in the Bleeding Index [This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    The Bleeding index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.

  7. Change in the Probing Depth [Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    This will be measured in millimeters from the gingival margin to the bottom of the sulcus/pocket around the six anterior teeth.

  8. Change in the Gingival Recession [Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.]

    This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adult healthy patients, Male and female, Age range: 15-27 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. 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: Rashad Ibrahem Shaadouh, DDS, Department of orthodontics, Damascus University, Syria
  • Study Director: Mohammad Y Hajeer, DDS,MSc,PhD, Department of orthodontics, Damascus University, Syria
  • Study Director: Ghiath Mahmoud, 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:
NCT05302076
Other Study ID Numbers:
  • UDDS-Ortho-05-2022
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 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
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022