Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
15 de abril de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
26
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Damascus, República Árabe Siria, 00963
- Orthodontic Department, University of Damascus Dental School
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 24 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Perception of Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patients' satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mohamad Radwan Sirri, DDS MSc, MSc student in Orthodontics, University of Damascus Dental School
- Silla de estudio: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, University of Damascus, Damascus, Syria
- Director de estudio: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de marzo de 2017
Finalización primaria (Actual)
15 de septiembre de 2018
Finalización del estudio (Actual)
15 de febrero de 2019
Fechas de registro del estudio
Enviado por primera vez
13 de abril de 2020
Primero enviado que cumplió con los criterios de control de calidad
15 de abril de 2020
Publicado por primera vez (Actual)
16 de abril de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- UDDS-Ortho-03-2020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .