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

NCT05350280 | Completed DMC

• 1 other identifier: UDDS-Ortho-06-2022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Malocclusion

Keywords

Electrical stimulation; Low-intensity electrical current (LIEC); En-masse retraction; Pain; Discomfort

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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 Outcomes (3)

• Change in Molars' positions

  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)

• Change in the inter-canine width

  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)

• Change in the inter-molar width

  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)

Study Arms (2)

Low-intensity electrical current (LIEC)

EXPERIMENTAL

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.

Device: electric current

Traditional fixed orthodontic appliance

ACTIVE COMPARATOR

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.

Device: Traditional treatment

Interventions

electric current DEVICE

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

Low-intensity electrical current (LIEC)

Traditional treatment DEVICE

No acceleration method will be performed in this group.

Traditional fixed orthodontic appliance

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)

• 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

• 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.

  PMID: 25738176 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

• 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.

  PMID: 29195495 BACKGROUND

• 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.

  PMID: 28937886 BACKGROUND

• Shaadouh RI, Hajeer MY, Awawdeh MA, Jaber ST, Mahmoud GA, Almasri IA. Effectiveness of low-intensity electrical current in accelerating the en-masse retraction of the upper anterior teeth following first-premolar extraction in young adult patients with Class II division 1 malocclusion: A randomized controlled clinical trial. Int Orthod. 2024 Dec;22(4):100921. doi: 10.1016/j.ortho.2024.100921. Epub 2024 Sep 23.

  PMID: 39316889 DERIVED

MeSH Terms

Conditions

Overbite; Pain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rashad I. 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: April 22, 2022
• First Posted: April 28, 2022
• Study Start: August 20, 2018
• Primary Completion: February 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)