Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone
Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.
Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.
A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.
The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.
The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beirut, Líbano, 1104 2020
- Saint-Joseph University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patient age: between 20 and 65
- No systematic contraindication for implant surgery
- No more than 10 cigarettes/day
- Previous horizontal bone augmentation 6 months prior to implant placement
- Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)
Exclusion Criteria:
- Smokers more than 10 cigarettes/day
- Pregnant/lactating women
- Alcoholics/drug addicts
- Uncontrolled diabetics, immunocompromised, blood hemostasis problems
- Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
- Patients not willing to sign the consent form
- History of radiotherapy in the head and neck region in the last 5 years
- Active periodontitis on the remaining teeth
Plan de estudios
¿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 |
|---|---|
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Experimental: External hex implant
External hexagone implant connection
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In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.
Otros nombres:
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Experimental: Internal hex implant
Internal implant connection
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In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.
Otros nombres:
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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 from baseline of alveolar ridge thickness at 4 months
Periodo de tiempo: During procedure and at 4 months
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Peroperative surgical measurements of the alveolar ridge width at implant sites
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During procedure and at 4 months
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Change from baseline of radiographic bone level on CBCT at 1 year post-op
Periodo de tiempo: During procedure and at 1 year
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CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
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During procedure and at 1 year
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Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
Periodo de tiempo: During procedure, at 4 months, at 6 months and 1 year
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Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
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During procedure, at 4 months, at 6 months and 1 year
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Change from baseline of bone plate thickness at 4 months
Periodo de tiempo: During procedure and at 4 months
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Peroperative buccal and lingual residual bone thickness following implant insertion
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During procedure and at 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insertion torque
Periodo de tiempo: During procedure
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Manual torque insertion are registered at implant placement.
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During procedure
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Change of Clinical parameters from baseline to 1 year post-op
Periodo de tiempo: During procedure, at 6 months and at 1 year
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FMBS, FMPS,
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During procedure, at 6 months and at 1 year
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Change of FMBS parameters from baseline to 1 year post-op
Periodo de tiempo: During procedure, at 6 months and at 1 year
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Change in full mouth bleeding score
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During procedure, at 6 months and at 1 year
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Change of Keratinized tissue height from Baseline to 4 months
Periodo de tiempo: During procedure and at 4 months
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Measured using a 1.0-mm marked periodontal probe
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During procedure and at 4 months
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Histological analysis
Periodo de tiempo: During procedure
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Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality
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During procedure
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Change of FMPS parameters from baseline to 1 year post-op
Periodo de tiempo: During procedure, at 6 months and at 1 year
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Change in full mouth plaque score
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During procedure, at 6 months and at 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nada Naaman, PhD, Saint-Joseph University
Publicaciones y enlaces útiles
Publicaciones Generales
- Donati M, Ekestubbe A, Lindhe J, Wennstrom JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23.
- Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennstrom JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492.
- Shi JY, Jie-Ni, Zhuang LF, Zhang XM, Fan LF, Lai HC. Peri-implant conditions and marginal bone loss around cemented and screw-retained single implant crowns in posterior regions: A retrospective cohort study with up to 4 years follow-up. PLoS One. 2018 Feb 5;13(2):e0191717. doi: 10.1371/journal.pone.0191717. eCollection 2018.
- Liu J, Kerns DG. Mechanisms of guided bone regeneration: a review. Open Dent J. 2014 May 16;8:56-65. doi: 10.2174/1874210601408010056. eCollection 2014.
- Koller CD, Pereira-Cenci T, Boscato N. Parameters Associated with Marginal Bone Loss around Implant after Prosthetic Loading. Braz Dent J. 2016 May-Jun;27(3):292-7. doi: 10.1590/0103-6440201600874.
- Wennerberg A, Hallgren C, Johansson C, Danelli S. A histomorphometric evaluation of screw-shaped implants each prepared with two surface roughnesses. Clin Oral Implants Res. 1998 Feb;9(1):11-9. doi: 10.1034/j.1600-0501.1998.090102.x.
- Rosa MB, Albrektsson T, Francischone CE, Schwartz Filho HO, Wennerberg A. The influence of surface treatment on the implant roughness pattern. J Appl Oral Sci. 2012 Sep-Oct;20(5):550-5. doi: 10.1590/s1678-77572012000500010.
- Esposito M, Ardebili Y, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD003815. doi: 10.1002/14651858.CD003815.pub4.
- Testori T, Wiseman L, Woolfe S, Porter SS. A prospective multicenter clinical study of the Osseotite implant: four-year interim report. Int J Oral Maxillofac Implants. 2001 Mar-Apr;16(2):193-200.
- Nevins M, Mellonig JT, Clem DS 3rd, Reiser GM, Buser DA. Implants in regenerated bone: long-term survival. Int J Periodontics Restorative Dent. 1998 Feb;18(1):34-45.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- FMD195
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- RSC
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.
producto fabricado y exportado desde los EE. UU.
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