- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05419778
Alveolar Ridge Preservation Procedures
Clinical Evaluation Of Soft Tissue Closure In Alveolar Ridge Preservation Procedures
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There will be two(2) groups of standardized treatment (tooth extractions will not take place for research purposes. The Periodontal clinic receives referred tooth extraction indications for treatment as part of the patient's overall treatment plan) evaluated for this study. Subjects will be randomized to either treatment a) standard of care treatment for tooth extraction and ridge augmentation procedures with Cytoplast GRB, or b) standard of the care treatment protocol and ridge augmentation procedures with Osteogen.
Each individual extraction site of the enrolled subject will be randomly assigned to Group A and/or Group B for the ridge augmentation procedure. It is possible for a subject to be randomized to both treatment groups. Randomization is like a "coin toss" prior to the initiation of the surgical procedure. The "coin toss" will be to define the procedure to be conducted for the smallest tooth number first. A computer-generated randomization assignment has been populated for the ridge augmentation assignments. The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation.The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to one of two(2) ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area. Excess tissue will be collected if the subject has a standard of care implant-related procedure where tissue could need to be removed for implant placement purposes. For example, if a patient undergoes a tooth extraction, ridge augmentation, and implant placement then any portion of the excised tooth and connective tissue will be kept for later analyses of histology discovery. No additional tissue will be collected for research purposes. There will be one screening visit, a treatment visit, and 7 post-operative follow-up visits at 1, 2, 3, 4, 6, 8, and 20 weeks. Subjects will visit the clinic a total of eight (9) times. Of the 9 visits, 1 visit is standard of care, 3 visits are a combined standard of care and research procedure visits and 5 are strictly for research purposes. The nonabsorbable membranes in the control will be removed after 4-6 weeks in a most atraumatic manner with the help of a tweezer without disturbing the underlying new connective tissue formation. As there is no need for removal of the absorbable membrane in the experimental group.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38163
- University of Tennessee Health Science Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
UT Clinic Participates
- Participates that live within 100 miles of UTHSC.
- Participates at least 12 years of age. If participants are 13-14 years of age, the premolars and molars will be included in this study. #2-15 & #18-31.
- Participates willing to cooperate with the post-operative instructions;
- Participates with 2 or more (multiples of 2) teeth needing Maxillary/mandibular and anterior/posterior teeth extractions without restrictions due to the percentage of surface area after the extraction and not interfering with the tooth's alveolar soft tissue exposed surface area.
- Participates with the availability of returning for 8 visits for data collection.
- Participants are willing to cooperate with answering the VAS and taking standardized photographs.
- Participants are physically able to tolerate surgical procedures based on current medical history.
- Participates able to provide voluntary consent; read and understand English
Exclusion Criteria:
- Participates with Diabetes
- History of use of bisphosphonates
- Current smoker
- If the participant is 12-13 years of age, the tooth/teeth to be removed will not be a primary tooth due to the permanent teeth developing underneath the primary teeth.
- Pregnant and lactating women
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Group A (Osteogen plug®)
The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation.
The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to receive treatment with a type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)(Osteogen) ridge augmentation procedures.
Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized.
At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area.
|
A type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)
|
Group B ( MInerOss® )
The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation.
The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to a cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane ridge augmentation procedures.
Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized.
At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area.
|
A cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Histological Bone Formation Changes
Periodo de tiempo: 4 weeks
|
histomorphometric evaluation of the grafted bone.
The area fraction (AF) of newly formed bone was measured automatically.
The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field.
The mean area fraction (MAF) for each case was calculated.
Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone
|
4 weeks
|
Histological Bone Formation Changes
Periodo de tiempo: 6 weeks
|
histomorphometric evaluation of the grafted bone.
The area fraction (AF) of newly formed bone was measured automatically.
The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field.
The mean area fraction (MAF) for each case was calculated.
Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone
|
6 weeks
|
Histological Bone Formation Changes
Periodo de tiempo: 20 weeks
|
histomorphometric evaluation of the grafted bone.
The area fraction (AF) of newly formed bone was measured automatically.
The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field.
The mean area fraction (MAF) for each case was calculated.
Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone
|
20 weeks
|
Clinical Dimensional Changes
Periodo de tiempo: 4 weeks
|
|
4 weeks
|
Clinical Dimensional Changes
Periodo de tiempo: 6 weeks
|
|
6 weeks
|
Clinical Dimensional Changes
Periodo de tiempo: 20 weeks
|
|
20 weeks
|
Evaluate Patient Pain
Periodo de tiempo: 20 weeks
|
Evaluate patient pain during the wound healing phase using the visual analog scale (VAS). Scale range (0-10) : 0 1 2 3 4 5 6 7 8 9 10 Minimum Value: 0 = no pain Maximum Value: 10 = worse pain ever imaged |
20 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cimara F Ferreira, PhD, University of Tennessee
Publicaciones y enlaces útiles
Publicaciones Generales
- Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011.
- Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
- Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x.
- Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
- McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.
- Molnar JA, Lew WK, Rapp DA, Gordon ES, Voignier D, Rushing S, Willner W. Use of standardized, quantitative digital photography in a multicenter Web-based study. Eplasty. 2009;9:e4. Epub 2009 Jan 12.
- Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. 1972. J Prosthet Dent. 2003 May;89(5):427-35. doi: 10.1016/s0022-3913(03)00158-6. No abstract available.
- Barber HD, Lignelli J, Smith BM, Bartee BK. Using a dense PTFE membrane without primary closure to achieve bone and tissue regeneration. J Oral Maxillofac Surg. 2007 Apr;65(4):748-52. doi: 10.1016/j.joms.2006.10.042.
- Wang HL, Boyapati L. "PASS" principles for predictable bone regeneration. Implant Dent. 2006 Mar;15(1):8-17. doi: 10.1097/01.id.0000204762.39826.0f.
- Kosinski T. A Simple and Cost-Effective Socket Preservation Technique. Dent Today. 2016 Apr;35(4):90, 92, 94-5. No abstract available.
- Feng L, Zhang L, Cui Y, Song TX, Qiu ZY, Wang XM, Tan BS. Clinical evaluations of mineralized collagen in the extraction sites preservation. Regen Biomater. 2016 Mar;3(1):41-8. doi: 10.1093/rb/rbv027. Epub 2016 Jan 19.
- Nevins M, Parma-Benfenati S, Janke UW, Kleyer A, Rasperini G, Tinti C, Schupbach P, Kim DM. The efficacy of mineralized allograft cortical and cancellous chips in maxillary sinus augmentations. Int J Periodontics Restorative Dent. 2014 Nov-Dec;34(6):789-93. doi: 10.11607/prd.1720.
- Park JC, Koo KT, Lim HC. The hidden X suture: a technical note on a novel suture technique for alveolar ridge preservation. J Periodontal Implant Sci. 2016 Dec;46(6):415-425. doi: 10.5051/jpis.2016.46.6.415. Epub 2016 Dec 26.
- Evian CI, Rosenberg ES, Coslet JG, Corn H. The osteogenic activity of bone removed from healing extraction sockets in humans. J Periodontol. 1982 Feb;53(2):81-5. doi: 10.1902/jop.1982.53.2.81.
- Dahlin C, Linde A, Gottlow J, Nyman S. Healing of bone defects by guided tissue regeneration. Plast Reconstr Surg. 1988 May;81(5):672-6. doi: 10.1097/00006534-198805000-00004.
- Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2017 Oct 6;10(10):CD012432. doi: 10.1002/14651858.CD012432.pub2.
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
Otros números de identificación del estudio
- 18-06428-FB
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.
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. .
Ensayos clínicos sobre Preservación de la cresta alveolar
-
University Hospital, MontpellierTerminadoFisura alveolar operada sobre injerto óseo alveolarFrancia
-
Cairo UniversityAún no reclutandoPreservación del alvéolo, Deficiencia de la cresta alveolar, Preservación de la cresta alveolar
-
Ivory Graft Ltd.TerminadoInjerto óseo alveolar | Deficiencia de la cresta alveolar (trastorno) | Usuario de prótesis mandibularIsrael
-
University of PittsburghTerminadoInjerto óseo alveolar | Injerto de hendidura alveolarEstados Unidos
-
Ivory Graft Ltd.Activo, no reclutandoInjerto óseo alveolar | Deficiencia de la cresta alveolar (trastorno) | Usuario de prótesis mandibularIsrael
-
Cairo UniversityReclutamiento
-
University of Sao PauloTerminado
-
National Cancer Institute (NCI)ReclutamientoSarcoma alveolar metastásico de partes blandas | Sarcoma alveolar de partes blandas irresecable | Sarcoma de tejido blando avanzado | Sarcoma alveolar avanzado de partes blandasEstados Unidos
-
October 6 UniversityMinistry of Health, KuwaitTerminadoHendidura alveolar | Hendidura de cresta alveolarKuwait
-
National Cancer Institute (NCI)ReclutamientoSarcoma alveolar metastásico de partes blandas | Sarcoma alveolar de partes blandas irresecableEstados Unidos
Ensayos clínicos sobre Osteogen plug®
-
Zimmer BiometTerminadoHueso de fractura de tibia sin uniónEstados Unidos
-
CMX ResearchTerminadoIncontinencia urinariaCanadá
-
Universitaire Ziekenhuizen KU LeuvenBytefliesActivo, no reclutando
-
RTI SurgicalTerminadoLesión de rodillaEstados Unidos
-
University of Alabama at BirminghamCollagen MatrixRetiradoTerapia de conducto radicularEstados Unidos
-
Dong-A ST Co., Ltd.TerminadoDispepsia funcionalCorea, república de
-
Chung-Ang University Hosptial, Chung-Ang University...DesconocidoDispepsia funcionalCorea, república de
-
Amir AzarpazhoohInstitut Straumann AGTerminadoInflamación periodontal | Alargamiento de coronaCanadá
-
Novartis PharmaceuticalsTerminadoEnfermedad Pulmonar Obstructiva Crónica (EPOC)Argentina
-
GuerbetTerminadoTumor cerebral primarioColombia, Corea, república de, Estados Unidos, México