search
Back to results

Evaluation of the Effect of Electrical Stimulation on the Rate of Orthodontic Tooth Movement and the Dental Arches

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
electric current
Traditional treatment
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring Electrical stimulation, Low-intensity electrical current (LIEC), En-masse retraction, Pain, Discomfort

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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
  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. Patient had previous orthodontic treatment

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-intensity electrical current (LIEC)

Traditional fixed orthodontic appliance

Arm Description

A removable device containing a small electrical circuit will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.

The maxillary arch will be levelled and aligned. (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.

Outcomes

Primary Outcome Measures

Rate of retraction
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
Change in Incisors' positions
Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.

Secondary Outcome Measures

Change in Molars' positions
Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Change in the inter-canine width
The change in the inter-canine width (mm/month) in each group will be calculated. Assessment will be performed on the dental casts by measuring the distance between the cusp tips of the two upper canines.
Change in the inter-molar width
The change in the inter-molar width (mm/month) in each group will be calculated. Assessment will be performed on the dental casts by measuring the distance between the central groove of the two first maxillary molars.

Full Information

First Posted
April 22, 2022
Last Updated
April 5, 2023
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05350280
Brief Title
Evaluation of the Effect of Electrical Stimulation on the Rate of Orthodontic Tooth Movement and the Dental Arches
Official Title
Evaluation the Effects of Low-intensity Electrical Current on the Rate of Orthodontic Tooth Movement, and Dentoalveolar Changes During En-masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Thirty-eight patients requiring extraction of maxillary first premolars and maximum anchorage to retract the 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 dental changes will be detected using dental casts and to evaluate the rate of teeth retraction.
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 8-10mm 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 the device for five hours a day until the completion of the retraction of the upper anterior. (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. Dental casts will be used for the quantification of the anteroposterior movement of the anterior teeth and the first molars every 30 days until class I canine relationship will be achieved and a good incisor relationship will be obtained. Photographs of the upper casts will be taken with a central vertical projection on the occlusal plane and with a millimeter scale at the same level used to standardize and calibrate the conditions to match the casts when photographing them. Reference points will be used for upper casts study and the measurements will be calculated using the Image J computer program. To evaluate the movement of the anterior teeth: we will project the incisive edge on the median line and measure the distance from this point to the projected position of the medial end of the third palatine wrinkle on the median line. To evaluate the movement of the first molars: we will project the mesial contact point of the first molar on the median line and measure the distance from this point to the to the projected position of the medial end of the third palatine wrinkle on the median line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Electrical stimulation, Low-intensity electrical current (LIEC), En-masse retraction, Pain, Discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-intensity electrical current (LIEC)
Arm Type
Experimental
Arm Description
A removable device containing a small electrical circuit will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.
Arm Title
Traditional fixed orthodontic appliance
Arm Type
Active Comparator
Arm Description
The maxillary arch will be levelled and aligned. (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.
Intervention Type
Device
Intervention Name(s)
electric current
Intervention Description
Electric current will be applied in this group of patients using removable device.
Intervention Type
Device
Intervention Name(s)
Traditional treatment
Intervention Description
No acceleration method will be performed in this group.
Primary Outcome Measure Information:
Title
Rate of retraction
Description
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
Time Frame
The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group.
Title
Change in Incisors' positions
Description
Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Time Frame
T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
Secondary Outcome Measure Information:
Title
Change in Molars' positions
Description
Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Time Frame
T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
Title
Change in the inter-canine width
Description
The change in the inter-canine width (mm/month) in each group will be calculated. Assessment will be performed on the dental casts by measuring the distance between the cusp tips of the two upper canines.
Time Frame
T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
Title
Change in the inter-molar width
Description
The change in the inter-molar width (mm/month) in each group will be calculated. Assessment will be performed on the dental casts by measuring the distance between the central groove of the two first maxillary molars.
Time Frame
T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients, Male and female, Age range: 15-27 years. 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 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 (corticosteroid, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashad I. Shaadouh, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS MSc PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ghiath Mahmoud, DDS MSc PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26917494
Citation
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.
Results Reference
background
PubMed Identifier
25738176
Citation
Kalemaj Z, DebernardI CL, Buti J. Efficacy of surgical and non-surgical interventions on accelerating orthodontic tooth movement: a systematic review. Eur J Oral Implantol. 2015 Spring;8(1):9-24.
Results Reference
background
PubMed Identifier
30771000
Citation
Zaniboni E, Bagne L, Camargo T, do Amaral MEC, Felonato M, de Andrade TAM, Dos Santos GMT, Caetano GF, Esquisatto MAM, Santamaria M Jr, Mendonca FAS. Do electrical current and laser therapies improve bone remodeling during an orthodontic treatment with corticotomy? Clin Oral Investig. 2019 Nov;23(11):4083-4097. doi: 10.1007/s00784-019-02845-9. Epub 2019 Feb 15.
Results Reference
background
PubMed Identifier
29195495
Citation
Jing D, Xiao J, Li X, Li Y, Zhao Z. The effectiveness of vibrational stimulus to accelerate orthodontic tooth movement: a systematic review. BMC Oral Health. 2017 Dec 1;17(1):143. doi: 10.1186/s12903-017-0437-7.
Results Reference
background
PubMed Identifier
28937886
Citation
Cadenas de Llano-Perula M, Yanez-Vico RM, Solano-Reina E, Palma-Fernandez JC, Iglesias-Linares A. Effectiveness of Biology-Based Methods for Inhibiting Orthodontic Tooth Movement. A Systematic Review. J Clin Pediatr Dent. 2017;41(6):494-502. doi: 10.17796/1053-4628-41.6.14. Epub 2017 Sep 22.
Results Reference
background

Learn more about this trial

Evaluation of the Effect of Electrical Stimulation on the Rate of Orthodontic Tooth Movement and the Dental Arches

We'll reach out to this number within 24 hrs