Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement

NCT05302076 | Completed DMC

• 1 other identifier: UDDS-Ortho-05-2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Malocclusion

Keywords

En-masse retraction; Acceleration; Low-intensity electric current

Outcome Measures

Primary Outcomes (4)

• Duration of 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.

  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.

• Change in the SN-U1 angle

  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.

  : 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.

• Change in the SNA angle

  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.

  : 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.

• Change in the MM angle

  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.

  : 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.

Secondary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

electric current

EXPERIMENTAL

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

Device: Low-intensity electrical current (LIEC)

Traditional treatment

ACTIVE COMPARATOR

No acceleration method will be performed in this group.

Device: Traditional fixed orthodontic appliance

Interventions

Low-intensity electrical current (LIEC) DEVICE

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.

electric current

Traditional fixed orthodontic appliance DEVICE

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.

Traditional treatment

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (6)

• 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

• 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

• 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.

  PMID: 30771000 BACKGROUND

• Chaudhari SD, Sharma KK, Marchetto JJ, Hydren JR, Burton BM, Moreno AP. Modulating OPG and TGF-beta1 mRNA expression via bioelectrical stimulation. Bone Rep. 2021 Oct 9;15:101141. doi: 10.1016/j.bonr.2021.101141. eCollection 2021 Dec.

  PMID: 34692946 BACKGROUND

• Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.

  PMID: 25072362 BACKGROUND

• Masella RS, Meister M. Current concepts in the biology of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):458-68. doi: 10.1016/j.ajodo.2005.12.013.

  PMID: 16627170 BACKGROUND

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rashad Ibrahem Shaadouh, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

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: March 20, 2022
• First Posted: March 31, 2022
• Study Start: August 23, 2019
• Primary Completion: February 12, 2021
• Study Completion: December 5, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)