Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement
5 de abril de 2021 actualizado por: University of Malaya
The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
Pain is the most claimed complaint from orthodontic treatment.
Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment.
For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain.
However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement.
This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage.
The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment.
This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
108
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.
Estudio Contacto
- Nombre: Poon Pei San
- Número de teléfono: 0127691145
- Correo electrónico: peisanpss@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Siti Adibah Othman, Prof
- Número de teléfono: 012-2635088
- Correo electrónico: sitiadibah@um.edu.my
Ubicaciones de estudio
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Wilayah Persekutuan Kuala Lumpur
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Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malasia, 50603
- Reclutamiento
- Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya
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Contacto:
- Pei San Poon
- Número de teléfono: 0127691145
- Correo electrónico: peisanpss@gmail.com
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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
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances
- Orthodontic treatment include the extraction of the permanent first or second premolars
- Age 16 years and above
Exclusion Criteria:
- Significant medical problem or cleft lip and palate.
- Pregnant lady
- Occurrence of using analgesics or antibiotics
- History of asthma or unstable asthma the last year
- Oral surgery in the previous 4 weeks
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: intervention group
Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum.
They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required.
Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain.
They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used.
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Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
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Sin intervención: Control group
Participants will not receive any prescription after the separators and initial arch wires placement.
They will be specifically asked not to chew chewing gum.
As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain assessment after separators and initial arch wire placement.
Periodo de tiempo: At 6 hours after separators and initial arch wire placement.
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Level of pain on the Numerical pain rating scale (NRS)
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At 6 hours after separators and initial arch wire placement.
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Pain assessment after separators and initial arch wire placement.
Periodo de tiempo: At 24 hours after separators and initial arch wire placement.
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Level of pain on the Numerical pain rating scale (NRS)
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At 24 hours after separators and initial arch wire placement.
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Pain assessment after separators and initial arch wire placement.
Periodo de tiempo: At 48 hours after separators and initial arch wire placement.
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Level of pain on the Numerical pain rating scale (NRS)
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At 48 hours after separators and initial arch wire placement.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reported use of chewing gum and analgesics.
Periodo de tiempo: Immediately after the separator and archwire placements until up to 6 hours
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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Immediately after the separator and archwire placements until up to 6 hours
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|
Reported use of chewing gum and analgesics.
Periodo de tiempo: from 6 hours to 24 hours after the separator and archwire placements
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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from 6 hours to 24 hours after the separator and archwire placements
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Reported use of chewing gum and analgesics.
Periodo de tiempo: from 24 hours to 48 hours after the separator and archwire placements
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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from 24 hours to 48 hours after the separator and archwire placements
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Recorded appliances breakages.
Periodo de tiempo: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
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Frequency of appliances breakages
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Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Siti Adibah Othman, Prof, Faculty Of Dentistry, University of Malaya
- Director de estudio: Zamros Yuzadi Mohd Yusof, Prof, Faculty Of Dentistry, University of Malaya
- Investigador principal: Poon Pei San, Faculty Of Dentistry, University of Malaya
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
- Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020.
- Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22.
- Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018.
- Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
- Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1.
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)
6 de marzo de 2019
Finalización primaria (Anticipado)
1 de agosto de 2021
Finalización del estudio (Anticipado)
1 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
5 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
5 de abril de 2021
Publicado por primera vez (Actual)
8 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
5 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DGD170001
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. .