Clinical trial NCT05302076: Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: En-masse retraction
Acceleration
Low-intensity electric current
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of en-masse retraction of anterior teeth
timeFrame: 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.
measure: Change in the SN-U1 angle
timeFrame: : 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.
measure: Change in the SNA angle
timeFrame: : 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.
measure: Change in the MM angle
timeFrame: : 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:
measure: Change in the Nasolabial angle
timeFrame: : 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.
measure: Change in the Li-E Line
timeFrame: : 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.
measure: Change in Root Length
timeFrame: 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.
measure: Change in the Plaque index
timeFrame: 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.
measure: Change in the Gingival Index
timeFrame: 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.
measure: Change in the Bleeding Index
timeFrame: 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.
measure: Change in the Probing Depth
timeFrame: 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.
measure: Change in the Gingival Recession
timeFrame: 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.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Rashad Ibrahem Shaadouh, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Ghiath Mahmoud, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
citation: 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.
citation: 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.
citation: 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.