Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes (IMPLA-CHA)
31 de agosto de 2026 actualizado por: Plovdiv Medical University
Evaluation of the Success of Immediate Implants in the Molar Region Using Individually Fabricated Healing Abutments (Sulcus Formers) in Different Classes of Post-Extraction Sockets: A Prospective Cohort Study
Immediate implant placement into a fresh extraction socket shortens overall treatment time and reduces the number of surgical procedures, but the fit between the implant and the socket walls, and the resulting soft-tissue contour, differ substantially between socket types. This study evaluates immediate implant placement in the molar and posterior region combined with an individually fabricated (customized) healing abutment, or sulcus former, that seals the socket and shapes the emergence profile from the day of surgery.
Consecutive patients with a non-restorable posterior tooth are treated with flapless atraumatic extraction, immediate implant placement, grafting of the residual gap, and a chairside customized healing abutment fabricated on a titanium temporary abutment. Participants are grouped by the class of the post-extraction socket (A, B or C) according to the interradicular septal bone available for primary stability.
Outcomes are preservation of peri-implant soft-tissue volume assessed with an intraoral scanner, preservation of alveolar bone volume assessed on cone-beam computed tomography, implant stability measured by resonance frequency analysis (ISQ) at placement and before loading, and time to definitive loading. Early wound healing on the Landry index, the degree of bone corticalization before loading, implant survival, healing-abutment complications and analgesic requirement are also recorded.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
60
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: Lyubomir Chenchev, DMD, PhD
- Número de teléfono: +359 887 102 516
- Correo electrónico: lyubomir.chenchev@mu-plovdiv.bg
Ubicaciones de estudio
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Plovdiv, Bulgaria, 4000
- Reclutamiento
- Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv
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Contacto:
- Lyubomir Chenchev, DMD, PhD
- Número de teléfono: +359 887 102 516
- Correo electrónico: lyubomir.chenchev@mu-plovdiv.bg
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Consecutive adult patients attending the Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv, with a non-restorable posterior (premolar or molar) tooth indicated for extraction and suitable for immediate implant placement.
Descripción
Inclusion Criteria:
- Age 18 years or over
- ASA physical status I or II
- A non-restorable posterior tooth (premolar or molar) indicated for extraction: clinically unrestorable crown, advanced chronic periodontitis, failed or untreatable endodontic therapy, or vertical root fracture
- Residual bone permitting implant placement with adequate primary stability
- Able and willing to give written informed consent and to attend the follow-up schedule
Exclusion Criteria:
- ASA physical status III or higher
- Pregnancy or lactation
- Uncontrolled diabetes mellitus
- Smoking more than 10 cigarettes per day
- Drug or alcohol abuse
- Current or previous bisphosphonate or other antiresorptive therapy
- Head and neck radiotherapy
- Immunosuppression
- Anticoagulant or antiplatelet therapy where the required pre-operative preparation is declined
- Psychiatric conditions preventing compliance with the study procedures
- Known titanium allergy
- Severe bruxism
- Acute infection at the surgical site
- Advanced alveolar resorption precluding immediate implant placement
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Socket class A
Posterior extraction socket in which the interradicular septal bone is sufficient to house the implant, giving circumferential bone contact along its coronal part.
Because a molar socket is frequently 10 mm or more across, a residual void commonly remains around the implant within the socket.
Participants receive immediate implant placement with a chairside customized healing abutment.
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Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
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|
Socket class B
Posterior extraction socket in which the septal bone is sufficient to stabilise the implant but not to house it, so that part of the implant surface faces the socket rather than bone.
Participants receive immediate implant placement with a chairside customized healing abutment.
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Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
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|
Socket class C
Posterior extraction socket with little or no septal bone, so that primary stability must be obtained from the peripheral socket walls and/or the bone apical to the socket.
Participants receive immediate implant placement with a chairside customized healing abutment.
|
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone.
Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact.
No barrier membrane is used.
Definitive loading is planned at three months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in peri-implant soft-tissue volume
Periodo de tiempo: Baseline, 3 months after placement (before loading), and 2 weeks after loading
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Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans.
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Baseline, 3 months after placement (before loading), and 2 weeks after loading
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Time to definitive loading
Periodo de tiempo: Up to 6 months after implant placement
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Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient.
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Up to 6 months after implant placement
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Implant stability quotient (ISQ)
Periodo de tiempo: At implant placement and at 3 months after placement (before loading)
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Implant stability measured by resonance frequency analysis on the ISQ scale from 1 to 100, where higher values indicate greater stability.
Stability before loading is the criterion that determines whether the implant is loaded at three months.
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At implant placement and at 3 months after placement (before loading)
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Change in alveolar bone volume
Periodo de tiempo: Baseline and 3 months after placement (before loading)
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Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography.
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Baseline and 3 months after placement (before loading)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Early wound healing
Periodo de tiempo: Days 7 and 14 after surgery
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Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.
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Days 7 and 14 after surgery
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Analgesic requirement
Periodo de tiempo: First 5 days after surgery
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Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.
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First 5 days after surgery
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Customized healing abutment complications
Periodo de tiempo: From surgery to definitive loading, up to 4 months
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Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent.
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From surgery to definitive loading, up to 4 months
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Implant survival
Periodo de tiempo: Up to 24 months after implant placement
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Proportion of implants in situ and functional at the latest follow-up visit.
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Up to 24 months after implant placement
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Peri-implant bone corticalization
Periodo de tiempo: 3 months after placement (before loading)
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Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index.
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3 months after placement (before loading)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tasho Gavrailov, DMD, PhD, Medical University of Plovdiv
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)
1 de abril de 2024
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Resorción ósea
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Atrofia periodontal
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades de la mandíbula
- Enfermedades de los dientes
- Boca desdentada
- Mandíbula Desdentada
- Pérdida ósea alveolar
- Pérdida de dientes
- Mandíbula Desdentada Parcialmente
Otros números de identificación del estudio
- NO-18/2025
- R-KNE-55/10.11.2025 (Otro identificador: Committee on Scientific Ethics, Medical University of Plovdiv)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be made publicly available.
De-identified data supporting the published analyses are available from the corresponding author on reasonable request.
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. .