- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07678892
10 Year Follow-up on Reconstructive Bone Procedures for Peri-implantitis (periimpl10y)
10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study
The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes.
Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this 10-year observational follow-up study was to investigate the long-term clinical and radiographic outcomes of reconstructive surgical treatment and to evaluate potential differences between two reconstructive treatment protocols.
The study population consisted of patients previously treated for per-implantitis using one of the following approaches.
Group 1: Surgical treatment using a bone substitute material (Algipor) combined with a barrier membrane (Osseoquest)
Group 2: Surgical treatment using a bone substitute materail alone (Algipor)
At the time of treatment, all patients received systemic antibiotic therapy consisting of Amoxicillin 375 mg three times daily and Metronidazole 400 mg twice daily for 10 days, initiated one day before surgery.
The study aimed to provide further knowledge regarding the long-term effectiveness and stability of reconstructive peri-implantitis treatment and to investigate potential differences between the two treatment modalities.
Following surgery all patients participated in a structured supportive maintanance program with supportive periodontal therapy every third month and annual clinical evaluations.
At the 10 year follow-up examination, the implant(s) was assessed clinically and radiographically. Clinical parameters included probing pocket depht, bleeding on probing, suppuration, plaque accumulation and implant survival. Probing measurements were performed using a standardized probing force of 0.25 N with a calibrated periodontal probe.
Bleeding scores were recorded at four sites per implant using the following scale:
0=no bleeding
- bleeding point
- bleeding line
- drop of blood
Plaque accumulation was recorded as present or absent, following plaque disclosure.
To minimize examiner variability, all clinical examinations was performed by the same periodontist.
The primary outcome measures were radiographic bone fill and changes in probing pocket depth at treated implant sites. Secondary outcome measures included bleeding on probing, suppuration, plaque scores, and implant survival.
Statistical analyses were performed using parametric or non-parametric methods depending on data distribution. Statistical significance was defined as p< 0.05.
Patients received both oral and written information regarding the study and provided written informed consent prior to participation. Participation was voluntary and the participants could withdraw from the study at any time without consequences. The study had received approval from the appropiate ethical reiew authority.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Kristianstad
-
Kristianstad, Kristianstad, Suecia, 29198
- Kristianstad University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- An implant demonstrating a progressive bone loss of ≥ 3 threads ( ≥ 1,8 mm) following the first year of healing
- A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure
- Bleeding on probing and/or suppuration should also be present
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group 1
Bone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest)
|
Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane
|
|
Group 2
Bone reconstructive surgery with a bone graft material (Algipor)
|
Dental, implants with a diagnosis of peri.implantitis
treated with reconstructive surgery and a bone graft alone
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bone fill
Periodo de tiempo: 10 years after surgical reconstrucyive bone procedures
|
Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph.
Measurements will be performed by a blinded radiologist in mm and percent
|
10 years after surgical reconstrucyive bone procedures
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Probing pocket depths changes
Periodo de tiempo: 10 years after surgical reconstructive bone procedures
|
Changes in probing pocket depths at the implant measured at four sites in mm
|
10 years after surgical reconstructive bone procedures
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bleeding
Periodo de tiempo: 10 years after surgical reconstructive bone procedures
|
Bleeding on probing measured at the implant at four sites as present or absent
|
10 years after surgical reconstructive bone procedures
|
|
Graded bleeding
Periodo de tiempo: 10 years after surgical reconstructive bone procedures
|
Graded bleeding measured at the implant at four sites as: 0=no bleeding 1= point of bleeding 2=line of bleeding and 3=drop of bleeding
|
10 years after surgical reconstructive bone procedures
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ann-Marie R Jansåker, Malmö University
Publicaciones y enlaces útiles
Publicaciones Generales
- Roos-Jansaker AM, Persson GR, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. J Clin Periodontol. 2014 Nov;41(11):1108-14. doi: 10.1111/jcpe.12308. Epub 2014 Oct 17.
- Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.
- Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a prospective cohort study. J Clin Periodontol. 2007 Jul;34(7):625-32. doi: 10.1111/j.1600-051X.2007.01102.x.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- P-I reconstructive surg 10 y
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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. .