Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
19 de mayo de 2022 actualizado por: Christopher Barwacz
Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.
The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.
Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.
The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.
Tipo de estudio
Intervencionista
Inscripción (Actual)
61
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
-
-
Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa College of Dentistry
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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
18 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18 years of age or greater
- Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
- Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
- An opposing dentition with teeth, implants, or fixed prosthesis
- Subjects must be willing to follow instructions related to the study procedures
- Subjects must have read, understood, and signed the informed consent document
Exclusion Criteria:
Exclusion Criteria:
- Insufficient interocclusal space for implant placement and/or restoration at study site
- More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
- Untreated rampant caries
- Tobacco use free for ≤ 6 months
- Liver or kidney disfunction/failure
- Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
- Uncontrolled diabetes
- Current alcohol or drug abuse
- Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- History of relevant head/neck cancer and/or radiation of the head/neck
- Subjects who currently use bisphosphonates or have a history of bisphosphonate use
- Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
- Known pregnancy or nursing mothers
- Unable or unwilling to return for follow-up visits for a period of 1 year
- Unlikely to be able to comply with study procedures according to investigators judgement
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Divergent Abutment
Divergent Transition Profile
|
An Atlantis abutment is delivered with a linear transition profile
|
|
Experimental: Concave Abutment
Concave Transition Profile
|
An Atlantis abutment is delivered with a concave transition profile.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Periodo de tiempo: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
|
Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
Periodo de tiempo: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
|
Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
|
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Periodo de tiempo: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
|
Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christopher A Barwacz, DDS, University of Iowa
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)
30 de diciembre de 2013
Finalización primaria (Actual)
3 de octubre de 2018
Finalización del estudio (Actual)
3 de octubre de 2018
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2013
Publicado por primera vez (Estimar)
6 de junio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 201302798
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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