Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Te… (NCT05920525) | Clinical Trial Compass
CompletedNot Applicable
Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement
Syria40 participantsStarted 2021-03-15
Plain-language summary
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.
Who can participate
Age range
17 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult healthy patients of both sexes
. Age range: 17-25 years.
. Class II Division 1 malocclusion:
. The presence of all permanent upper teeth (regardless of third molars).
. Good oral and periodontal health:
Exclusion criteria
. Patients with previous orthodontic treatment.
. Patients with severe skeletal dysplasia in all three dimensions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is already completed, has the data been published yet, and would you be able to share what the results showed about pain and discomfort levels when using electrical stimulation for moving teeth?
2How does electrical stimulation to speed up orthodontic tooth movement compare to standard braces treatment for Class II Division 1 malocclusion in terms of how much discomfort I might experience day to day?
3Given that this study specifically measured pain and discomfort as its main outcomes rather than long-term effectiveness, what do we actually know so far about whether electrically accelerated tooth movement works as well as conventional orthodontic approaches?
4Would the use of electrical stimulation devices during orthodontic treatment be something relevant to my specific case of Class II malocclusion, and are there any patients for whom this approach might not be appropriate?
5If the completed trial showed that electrical stimulation causes acceptable levels of pain and discomfort, does that mean this technique might become available as part of my treatment plan, or is there still more research needed before it's routinely offered?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the perception of pain
Timeframe: 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
2
Change in the perception of discomfort
Timeframe: 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