Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
15 апреля 2020 г. обновлено: Damascus University
The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth: Randomized Clinical Trial
The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.
Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.
Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.
No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.
Тип исследования
Интервенционный
Регистрация (Действительный)
26
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Damascus, Сирийская Арабская Республика, 00963
- Orthodontic Department, University of Damascus Dental School
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 24 года (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Exclusion Criteria:
- Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
- Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
- Patients had previous orthodontic treatments
- Poor oral hygiene or concurrent periodontal disease
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Corticision
Patients will undergo a corticision procedure in order to accelerate tooth movement
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Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement.
Three incisions are going to be made
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Активный компаратор: Traditional treatment
Patients will undergo traditional orthodontic treatment without any surgical intervention.
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No surgical intervention will be used, just normal orthodontic sequence of procedures.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in the Perception of Pain
Временное ограничение: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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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).
The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Discomfort
Временное ограничение: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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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 discomfort (VAS=100).
The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Swelling
Временное ограничение: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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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 swelling (VAS=100).
The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Levels of Difficulties in Mastication
Временное ограничение: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced.
The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100).
The level of difficulties in mastication is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Analgesic Consumption
Временное ограничение: The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1.
Yes or 2. No), and their quantity by mentioning how many tablets they took.
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The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patients' satisfaction
Временное ограничение: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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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).
The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Ease of the procedure
Временное ограничение: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Procedure's easiness 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 ease.
The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100).
The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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The possibility of repeating the procedure
Временное ограничение: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision 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).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Recommendation to a friend
Временное ограничение: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision 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).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Mohamad Radwan Sirri, DDS MSc, MSc student in Orthodontics, University of Damascus Dental School
- Учебный стул: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, University of Damascus, Damascus, Syria
- Директор по исследованиям: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
- Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
- Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
- Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.
- Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
15 марта 2017 г.
Первичное завершение (Действительный)
15 сентября 2018 г.
Завершение исследования (Действительный)
15 февраля 2019 г.
Даты регистрации исследования
Первый отправленный
13 апреля 2020 г.
Впервые представлено, что соответствует критериям контроля качества
15 апреля 2020 г.
Первый опубликованный (Действительный)
16 апреля 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 апреля 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 апреля 2020 г.
Последняя проверка
1 апреля 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- UDDS-Ortho-03-2020
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .