"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction
4 de febrero de 2021 actualizado por: Postgraduate Institute of Dental Sciences Rohtak
"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"
Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems.
Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement.
Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with Angle's Class II division 1 malocclusion meeting selection criteria and are indicated for maxillary first premolar extraction, patients will be referred for extraction of the maxillary first premolars , treatment will be initiated by bonding preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, leveling and alignment will be done in all subjects, after insertion of 0.019"× 0.025" stainless steel arch wire, alginate impression and periapical radiograph of canine and first molar region will be taken(Before the initiation of canine retraction), randomisation and allocation of two sides of maxillary arch i.e. right and left will be done and active interventions(piezocision and micro-osteoperforations) for each side will be done, immediately maxillary canine retraction will be started with mini-implant and closed NiTi coil spring, patient will be asked to fill pain and discomfort assessment card immediately after initiation of canine retraction., subsequent impressions records will be taken at 4th, 8th, 12th and 16th weeks for measuring rate of maxillary canine retraction, data collection and interpretation of results, further pain assessment cards will be filled after 24 hours, on 7th day and 28th day
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
20
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
-
-
Haryana
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Rohtak, Haryana, India, 124001
- Reclutamiento
- Post Graduate Institute of Dental Sciences
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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 a 25 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with age between 16-25 years
- Patients with Angle's class II division 1 malocclusion requiring bilateral extraction of maxillary first premolars.
- Overjet of ≤ 10mm
- No debilitating systemic disease.
- No radiographic evidence of bone loss.
- No history of periodontal disease/ therapy.
- No smoking habit.
- Probing depth of not more than 3mm in all teeth.
Exclusion Criteria:
- Presence of any signs and symptoms of gingival and periodontal diseases.
- Overjet more than 10mm.
- Long-term drug history.
- Systemic diseases.
- Evidence of bone loss.
- Smoking habit.
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: Piezocision on Experimental Side A
Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction
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Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome.
These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle .
The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.
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Experimental: Micro-osteoperforations on Experimental side B
Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction
|
Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2).
These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised.
The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added.
The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of rate of canine retraction
Periodo de tiempo: 4th week
|
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction
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4th week
|
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Measurement of rate of canine retraction
Periodo de tiempo: 8th week
|
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction
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8th week
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Measurement of rate of canine retraction
Periodo de tiempo: 12th week
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Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction
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12th week
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Measurement of rate of canine retraction
Periodo de tiempo: 16th week
|
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction
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16th week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of pain/discomfort level
Periodo de tiempo: at the beginning of canine retraction
|
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
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at the beginning of canine retraction
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Assessment of pain/discomfort level
Periodo de tiempo: 24 hours
|
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
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24 hours
|
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Assessment of pain/discomfort level
Periodo de tiempo: 7th day
|
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
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7th day
|
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Assessment of pain/discomfort level
Periodo de tiempo: 28th day
|
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
|
28th day
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
25 de diciembre de 2020
Finalización primaria (Anticipado)
1 de septiembre de 2021
Finalización del estudio (Anticipado)
1 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
14 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
4 de febrero de 2021
Publicado por primera vez (Actual)
8 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
4 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Karan.mahendru
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
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