Evaluation of the Effect of Electrical Stimulation on the Speed of Orthodontic Tooth Movement, the Related Changes in the Dental Arches, Pain and Discomfort
Study Details
Study Description
Brief Summary
Thirty-two 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. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 8-10mm 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.
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.
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.
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales. 24 hours following the springs activation (T1), three days (T2), one week (T3)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-intensity electrical current (LIEC) 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
Electric current will be applied in this group of patients using removable device.
|
| Active Comparator: Traditional fixed orthodontic appliance 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
No acceleration method will be performed in this group.
|
Outcome Measures
Primary Outcome Measures
- Rate of retraction [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.]
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 [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)]
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.
- 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)]
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.
Secondary Outcome Measures
- Change in the Perception of Pain [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of pain (Item no 01): 'What is the degree of pain accompanies this moment?' Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100).
- Change in the Perception of discomfort [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of discomfort (Item no 02): 'What is the degree of discomfort accompanies this moment?' Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum (unimaginable) discomfort (VAS=100).
- Change in the Perception of burning [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of burning (Item no 03): 'Do you have any burning where the electrical current is applied?' Burning is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of burning being experienced. The left end of the line refers to no burning (VAS=0) where the right end refers to maximum (unimaginable) burning (VAS=100).
- Change in the Perception of Swelling [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of Swelling (Item no 04): 'Do you have any Swelling where the electrical current is applied?' Swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of Swelling being experienced. The left end of the line refers to no Swelling (VAS=0) where the right end refers to maximum (unimaginable) Swelling (VAS=100).
- Change in swallowing ability [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of swallowing ability (Item no 05): 'what is the degree of swallowing difficulties? ' difficulty in swallowing is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in swallowing being experienced. The left end of the line refers to no difficulty (VAS=0) where the right end refers to maximum
- Change in the perception of speech [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about their perception of speech (Item no 06): ''what is the degree of speech difficulties?' Difficulty in speech is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in speech being experienced. The left end of the line refers to no difficulty (VAS=0) where the right end refers to maximum (unimaginable) difficulty (VAS=100).
- Analgesic Consumption [Questionnaires will be filled at the following assessment times: at the 1st,3rd, and 7th days following each activation of retraction coil]
Patients will be asked this question about Analgesic Consumption (Item no 07): 'Did you need to take pain analgesics?' Analgesic Consumption is assessed by asking the study participant about taking analgesics using a two-point scale (1. Yes, or 2. No).
- Patients' satisfaction [Questionnaires will be filled at the end of the retraction phase]
Patients will be asked this question about satisfaction with orthodontic treatment (Item no 01): 'How satisfied are you with your orthodontic treatment?' Satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100).
- Ease of the procedure [Questionnaires will be filled at the end of the retraction phase]
Patients will be asked this question about Ease of the procedure (Item no 02): 'Was it getting used to the accelerating device? ' Procedure's easiness is assessed by asking the participant in the experimental group using a three-point scale (1. easy, 2. Medium or 3. difficult).
- The possibility of repeating the procedure [Questionnaires will be filled at the end of the retraction phase]
Patients will be asked this question about The possibility of repeating the procedure (Item no 03): 'Would you accept to undergo this treatment again?' Patients in the experimental group will be asked about the possibility of repeating the procedure if they had the chance to give their decision again. The answer will be collected using a two-point scale (1. Yes, or 2. No).
- Recommendation to a friend [Questionnaires will be filled at the end of the retraction phase]
Patients will be asked this question about The Recommendation to a friend (Item no 04( 'Would you recommend a friend to undergo this treatment?' Patients in the experimental group will be asked about if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes, or 2. No).
- Change in Tooth Vitality [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.]
Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll. The tooth is considered vital (i.e. positive outcome) when there is a sensation of coldness announced by the patient once the Ethyl Chloride cotton roll touches the tooth crown. The tooth is considered non-vital (i.e. negative outcome) when an absence of response is observed by the examiner once the Ethyl Chloride cotton roll touches the tooth crown. These responses will be recorded (i.e. a binary outcome measure).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult healthy patients, Male and female, Age range: 15-27 years.
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Class II Division 1 malocclusion:
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Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
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Overjet ≤10
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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)
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Mild to moderate crowding ≤ 4
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Permanent occlusion.
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Existence of all the upper teeth (except third molars).
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Good oral and periodontal health:
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Probing depth < 4 mm
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No radiographic evidence of bone loss.
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Gingival index ≤ 1
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Plaque index ≤ 1
Exclusion Criteria:
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Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
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Presence of primary teeth in the maxillary arch
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Missing permanent maxillary teeth (except third molars).
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Poor oral hygiene or Current periodontal disease:
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Probing depth ≥ 4 mm
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radiographic evidence of bone loss
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Gingival index > 1
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Plaque index > 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
- Cadenas de Llano-Pérula M, Yañez-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. Review.
- 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. Review.
- 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. Review.
- 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.
- Zaniboni E, Bagne L, Camargo T, do Amaral MEC, Felonato M, de Andrade TAM, Dos Santos GMT, Caetano GF, Esquisatto MAM, Santamaria M Jr, Mendonça 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.
- UDDS-Ortho-06-2022