- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01934530
A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants
Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy adults of at least 18 years of age
- Maxillary non-molar implant with failing pink esthetic profile
- Implants with adjacent landmarks (only one can be an implant)
- Healthy implants measured by the lack of peri-implantitis and mucositis
- Good oral hygiene.
Exclusion Criteria:
- Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
- History of radiation or cancer in the oral cavity
- Use of IV bisphosphonate or steroid medication
- Use of tobacco products (>1/2 pack per day)
- Pregnancy
- Mucogingival surgery or implant placement within the past six months
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 |
---|---|
Comparador activo: Connective Tissue Graft - Control
The donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars.
A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin.
A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique.
The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension.
Follow up was monitored over 6 months at various time-points.
|
All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. |
Experimental: Alloderm - Test
ADM graft was prepared according to the manufacturer's instructions.
The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice.
The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum.
The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface.
There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue.
With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed.
The graft was sutured with a single sling and the flap with a double sling.
Simple interrupted sutures were used to close vertical releases.
|
All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recession Correction
Periodo de tiempo: 6 Months
|
Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
|
6 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Concavity Correction
Periodo de tiempo: 6 Months
|
At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.
|
6 Months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tissue Thickness
Periodo de tiempo: 6 Months
|
Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting.
|
6 Months
|
Implant Esthetics
Periodo de tiempo: 6 Months
|
Implant esthetics were rated with written survey by both the subject and clinician.
|
6 Months
|
Psychosocial Data
Periodo de tiempo: 6 months
|
Subjects completed questionnaires regarding their quality of life during the study by written survey.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Hom-Lay Wang, DDS, MS, PhD, University of Michigan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Otros números de identificación del estudio
- UM-Anderson-10
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. .
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