An interventional study of Electrical stimulation and Traditional retraction of the front upper teeth in Class II Malocclusion, Division 1, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 17 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
Forty patients with class II division 1 malocclusion who will require extraction of the upper first premolars as a part of the orthodontic treatment plan will be invited to participate in the study. They will be divided randomly into two groups: the electrical group and the control group. The en-masse retraction technique will be used to retract the upper anterior teeth using mini-implants as an anchor unit to provide the maximum anchorage and Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the crimpable hooks on the base wire and applied 250 g of force per side.
A special removable electrical device will be used to provide electrical stimulation during the retraction phase.
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.
Participants will be chosen from the patients attending the Department of Orthodontics in the Faculty of Dentistry at Damascus University. patients will be examined by the researcher, and any patient with class II division I malocclusion who meets the inclusion criteria will invite to participate in this trial. After giving them the information sheet, informed consent will be obtained from all patients who agreed to join the study.
Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0.022 x 0.028-inch slot metal bracket with MBT prescription; the conventional wiring sequence will be followed until a 0.019 x 0.025 Stainless Steel base wire is attached.
The maxillary first premolars will be extracted, and skeletal anchoring will be applied before leveling and alignment will begin for all patients. self-drilling orthodontic mini-implants (diameter: 1.6 mm; length: 8 mm) will be placed between the roots of the maxillary second premolar and the first molar on each side.
The en-masse retraction will be done using Nickle-Titanium (NiTi) closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side. The force will be examined using a force gauge at every appointment (two weeks) until the completion of the retraction of the upper anterior (reaching a class I canine relationship and a correct incisor relationship).
A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit. Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily.
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), and one week (T3).
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 40 is above the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
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Class II Division 1 malocclusion:
Good oral and periodontal health:
Exclusion Criteria:
In this group of patients, retraction of upper anterior teeth will be done using backward traction, and the remodeling will be enhanced by very light electrical stimulation by a specific device.
Device: Electrical stimulation
In this group of patients, traditional traction of the front teeth will be employed without any acceleration method.
Procedure: Traditional retraction of the front upper teeth
A specific device will be used to stimulate the remodeling procedures in the alveolar bone.
The retraction will be performed using coil springs which will help in moving the anterior teeth backward without the need to employ any additional procedure or device to accelerate this movement.
Change in the perception of pain
Patients will be asked this question about their perception of pain. 'What is the degree of pain accompanying 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), whereas the right end refers to maximum (unimaginable) pain (VAS=100).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of discomfort
Patients will be asked this question about their perception of discomfort. 'What is the degree of discomfort that 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), whereas the right end refers to maximum (unimaginable) discomfort (VAS=100).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of burning
Patients will be asked this question about their perception of burning. 'Do you feel any burning in the upper anterior teeth area?' 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), whereas the right end refers to maximum (unimaginable) burning (VAS=100).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of swelling
Patients will be asked this question about their perception of swelling. 'Do you feel any Swelling in the upper anterior teeth area?' 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), whereas the right end refers to maximum (unimaginable) Swelling (VAS=100).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the chewing ability
Patients will be asked this question about their perception of chewing ability. 'what is the degree of chewing difficulties? ' difficulty in chewing 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), whereas the right end refers to the maximum difficulty in mastication.
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the speech ability
Patients will be asked this question about their perception of speech ability. ''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), whereas the right end refers to maximum (unimaginable) difficulty (VAS=100).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Analgesic consumption
Patients will be asked this question about "Analgesic Consumption". '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).
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Patients' satisfaction
Patients will be asked this question about satisfaction with orthodontic treatment. '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), whereas the right end refers to maximum satisfaction (VAS=100).
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Ease of the procedure
Patients will be asked this question about the ease of the procedure. 'Was it getting used to the accelerating device? ' The 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).
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
The possibility of repeating the procedure
Patients will be asked this question about "The possibility of repeating the procedure. '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 can give their decision again. The answer will be collected using a two-point scale (1. Yes, or 2. No).
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Recommendation of the procedure to a friend
Patients will be asked this question about the possibility of recommending the procedure to their friends. 'Would you recommend a friend to undergo this treatment?' Patients in the experimental group will be asked if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes, or 2. No).
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Damascus University