Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Effect of Early vs Late Premolar Extraction on the Rate of Orthodontic Tooth Movement: A Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate whether the timing of premolar extraction affects the rate of orthodontic space closure during en-masse anterior retraction. The study will also assess gingival cleft formation, mesial movement of the upper first molars, ease and duration of premolar extraction, and patient-reported pain and anxiety.
The main question it aims to answer is:
Does early versus late premolar extraction affect the rate of orthodontic space closure?
Researchers will compare two groups of patients. In the early extraction group the maxillary first premolars will be extracted before or within one week of start of fixed orthodontic treatment. In the late extraction group, the premolars will be extracted after alignment and immediately before the start of space closure.
Participants will:
- Receive fixed orthodontic treatment and bilateral extraction of the maxillary first premolars.
- Be randomly assigned to either the early-extraction or late-extraction group.
- Undergo orthodontic alignment followed by en-masse anterior retraction.
- Have dental impressions/digital models obtained at the start of retraction and at 3 and 6 months to measure orthodontic tooth movement and space closure.
- Be assessed for gingival clefts and mesial movement of the upper first molars.
- Have the ease and duration of their premolar extraction recorded and report their pain and anxiety associated with the extraction procedure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized controlled trial will evaluate the effect of early versus late maxillary first premolar extraction on the rate of orthodontic space closure during en-masse anterior retraction. A total of 26 participants aged 13 to 25 years requiring bilateral maxillary first premolar extractions as part of their orthodontic treatment will be randomly allocated in a 1:1 ratio to an early-extraction or late-extraction group.
In the early-extraction group, the maxillary first premolars will be extracted before or within one week of fixed appliance placement. Participants will subsequently undergo leveling and alignment, and en-masse anterior retraction will begin after stabilization on a 0.019 × 0.025-inch stainless steel archwire. In the late-extraction group, leveling and alignment will be completed first using the same archwire sequence. The maxillary first premolars will then be extracted immediately before initiation of en-masse anterior retraction. Thus, space closure will occur through relatively healed extraction sites in the early-extraction group and relatively fresh extraction sites in the late-extraction group.
Orthodontic space closure will be assessed at baseline and at 3 and 6 months after initiation of retraction. Secondary assessments will include mesial movement of the maxillary first molars, incidence and severity of gingival clefts, ease and duration of premolar extraction, and patient-reported pain and anxiety. Digital models will be used to assess orthodontic tooth movement, while gingival clefts will be evaluated clinically.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shanzay Khan, BDS, Post Graduate Resident
- Número de teléfono: 03245555716
- Correo electrónico: shanzaykhan1997@gmail.com
Ubicaciones de estudio
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Islamabad, Pakistán, 44000
- Reclutamiento
- Shifa College Of Dentistry
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Contacto:
- Shanzay Khan
- Número de teléfono: 03245555716
- Correo electrónico: shanzaykhan1997@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 13-25 years
- No prior orthodontic treatment
- Overjet 4-8 mm
- Symmetric dental arches with mild to moderate crowding requiring bilateral first premolar extractions.
- Probing depth less than 4 mm on all teeth
Exclusion Criteria:
- History of dental trauma
- Poor oral hygiene
- Syndromic patients
- Systemic diseases or medications affecting bone metabolism
Plan de estudios
¿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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Comparador activo: Healed Socket Group (Control Group)
Maxillary first premolars will be extracted before or within one week of fixed orthodontic appliance placement.
Participants will subsequetly undergo leveling and alignment followed by en-masse anterior retraction after stabilization on a 0.019 x 0.025-inch stainless steel archwire.
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Bilateral extraction of the maxillary first premolars will be performed prior to or within one week of fixed orthodontic appliance placement, allowing the extraction sockets to heal during leveling and alignment before commencement of en-masse anterior retraction.
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Experimental: Unhealed Socket Group (Intervention Group)
Maxillary first premolars will be extracted after the participant has completed leveling and alignment, and has been stabilizad on a 0.019 x 0.025-inch stainless steel archwire for one month.
This will be followed immediately by en-masse anterior retraction.
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Bilateral extraction of the maxillary first premolars will be performed after completion of leveling and alignment and one month of stabilization on a 0.019 × 0.025-inch stainless steel archwire, immediately before commencement of en-masse anterior retraction.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models
Periodo de tiempo: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Intraoral scans will be obtained to generate digital 3D dental models at baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction.
The extraction space will be measured in millimeters as the linear distance between the highest convexity on the mesial surface of the maxillary second premolar and the distal surface of the maxillary canine.
The rate of space closure will be calculated as the reduction in extraction-space width over the corresponding observation period and expressed in millimeters per month (mm/month).
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence and Severity of Gingival Clefts Assessed Clinically Using a Periodontal Probe
Periodo de tiempo: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Gingival clefts will be assessed clinically using a periodontal probe.The presence, severity (depth and width in mm), and type (buccal, lingual, or through-and-through) of gingival clefts will be recorded.
Cleft severity will be assessed by measuring depth and width in millimeters.
Depth will be measured perpendicular to the occlusal plane, and the width will be measured parallel to the occlusal plane from the buccal and lingual aspect, with the greater of the two measurements recorded as the cleft width.
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Linear Mesial Movement of Maxillary First Molars Measured on Digital Models
Periodo de tiempo: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Measurements will be performed on digital dental models obtained by intraoral scanning.
Linear mesial movement of the maxillary first molars will be measured in millimeters.
Perpendicular reference lines to the mid-palatal suture will be constructed through the mesial contact point of the maxillary first molar and the medial end of the third palatal rugae.
The distance between these reference lines will be measured in millimeters.
The change in this distance from baseline (T0) to 3 months (T1) and from baseline to 6 months (T2) will represent linear mesial movement.
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Ease of Maxillary First Premolar Extraction Assessed by Surgeon-Rated 4-Point Likert Scale and Extraction Duration
Periodo de tiempo: Periprocedural
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Surgeon-perceived ease of extraction will be assessed using a 4-point Likert scale: 1 = very easy, 2 = easy, 3 = difficult, and 4 = very difficult, with higher scores indicating greater extraction difficulty.
Extraction duration will also be recorded from the time the forceps are clamped onto the tooth until the tooth is completely removed from the socket.
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Periprocedural
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Patient-Reported Pain and Dental Anxiety Associated With Premolar Extraction
Periodo de tiempo: Dental anxiety immediately before extraction; pain immediately following extraction.
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Pain will be assessed using a 0-10 Visual Analogue Scale, where 0 represents no pain and 10 represents the worst pain.
Dental anxiety will be assessed using a 5-item questionnaire, with each item rated from 1 (not anxious) to 5 (extremely anxious), giving a total score of 5-25.
Higher scores indicate greater pain or anxiety.
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Dental anxiety immediately before extraction; pain immediately following extraction.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 141-26
Información sobre medicamentos y dispositivos, documentos del estudio
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