Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.
Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)
The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone.
This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement.
The main questions this study aims to answer are:
Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique?
Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness?
participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique.
Participants will:
- Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
- Receive immediate implant placement using either the conventional technique or the socket-shield technique.
- Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
- Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Omar I Wahedi
- Número de teléfono: +201064769520
- Correo electrónico: wahdi3031@gmail.com
Ubicaciones de estudio
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Minya, Egipto
- Reclutamiento
- Minia University
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Contacto:
- Minia University
- Número de teléfono: 086 2347768
- Correo electrónico: ddent.office@mu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged between 20 and 60 years of both genders
- All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
- Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
- Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
- Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
- Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical.
- Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.
Exclusion Criteria:
(for socket-shield technique)
- Pregnant female.
- Patients with parafunctional habits (e.g., bruxism, clenching).
- Smokers.
- Teeth with clinical mobility.
- Teeth with root fractures extending below the alveolar bone level.
- Periodontal ligament space widening.
- Signs of internal or external root resorption.
- Current or previous periodontal disease
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: GROUP I
Immediate Implant Placement Using Conventional Technique
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Immediate Implant Placement Using Conventional Technique
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Experimental: GROUP II
Immediate Implant Placement Using Socket-Shield Technique
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Immediate Implant Placement Using Socket-Shield Technique
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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 Bone Density Around Immediate Implants.
Periodo de tiempo: At baseline of implant placement then after 9 months
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Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value. Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement Measure Description: Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone. |
At baseline of implant placement then after 9 months
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Change in Marginal Bone Level Around Immediate Implants.
Periodo de tiempo: At baseline of implant placement then after 9 months.
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At baseline of implant placement then after 9 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Probing Depth (PD)
Periodo de tiempo: 3 months, 6 months, and 9 months post-surgery.
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Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe. Unit of Measure: Millimeters (mm) |
3 months, 6 months, and 9 months post-surgery.
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Modified Gingival Index (MGI)
Periodo de tiempo: 3 months, 6 months, and 9 months post-surgery.
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Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation). Unit of Measure: Score on a scale (0-4) |
3 months, 6 months, and 9 months post-surgery.
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Modified Plaque Index (MPI)
Periodo de tiempo: 3 months, 6 months, and 9 months post-surgery.
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Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 :
Unit of Measure: Score on a scale (0-3) |
3 months, 6 months, and 9 months post-surgery.
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Gingival Thickness (GT)
Periodo de tiempo: Baseline, 3 months, 6 months, and 9 months post-surgery.
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Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin. Unit of Measure: Millimeters (mm) |
Baseline, 3 months, 6 months, and 9 months post-surgery.
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Width of Keratinized Tissue (KTW)
Periodo de tiempo: Baseline, 3 months, 6 months, and 9 months post-surgery.
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Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site. Unit of Measure: Millimeters (mm) |
Baseline, 3 months, 6 months, and 9 months post-surgery.
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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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MU-EC Research No.1187
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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