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Volumetric Analysis of Alveolar Ridge Contour Using Sub-epithelial Connective Tissue Graft

20 de julio de 2020 actualizado por: Nourhan Gamal AbdEl-Aziz, Cairo University

Post-extraction Volumetric Analysis of Alveolar Ridge Contour Using Subepithelial Connective Tissue Graft in Esthetic Zone: A Randomized Controlled Clinical Trial

This study will monitor the effect of soft tissue augmentation using sub-epithelial connective tissue graft buccal to extraction sockets in anterior maxilla in thin dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge contour and improve the gingival phenotype following atraumatic extraction compared with no treatment at all in terms of Ridge contour Preservation for future esthetically acceptable fixed prothesis.

Descripción general del estudio

Estado

Desconocido

Intervención / Tratamiento

Descripción detallada

The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.

Group A: Patients receiving atraumatic extraction with soft tissue augmentation by sub-epithelial connective tissue graft buccal to extraction sockets.

Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation

Clinical examination:

  • Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
  • Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the patient was excluded because of thick buccal bone, he/she will be referred for implant placement)
  • Evaluation of gingival phenotype before extraction using visual technique via periodontal probe.
  • After patient enrollment, full mouth scaling to be done first and home oral hygiene measures to be done by patient. At the day of the surgery, immediately before extraction, an impression will be taken using alginate material and wax molded stock tray for recording the original ridge contour as the baseline data. casts will be made with dental extra hard stone.

Surgical procedure:

After administration of local anesthesia, the tooth will be extracted without raising flaps, as atraumatic as possible without disturbing the papillary tissues. After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions.

Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.

The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place.

Pouch II technique:

A SCTG with a minimum thickness of 1.5 mm will be harvested from the palate. Following extraction, a full-thickness envelope flap will be created between the facial bone plate and the overlying gingiva. The SCTG will be inserted into the prepared envelope and secured with resorbable suture material. The apico-coronal dimension of the SCTG will be standardized throughout all the cases.

Group B will receive atraumatic extraction with no soft tissue augmentation.

(All patients assigned to the study will be referred to receive Prosthesis after treatment.)

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

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.

Estudio Contacto

Ubicaciones de estudio

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 40 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults from the age of 18 - 40 years
  • Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
  • Intact gingival tissue with at least 2mm keratinized tissue
  • Buccal bone thickness should be 1mm or less assessed by CBCT before extraction
  • Periodontally healthy patients
  • Patients accepts to provide informed consent

Exclusion Criteria:

  • Pregnant females.
  • Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
  • Handicapped and mentally retarded patients.
  • Patients undergoing radiotherapy.
  • Presence of systemic disease that would affect wound healing.
  • Presence of active infection with soft tissue communication.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SubEpithelial connective graft

SCTG harvested from palatal tissue by single line incision technique, blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.

The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation.

Connective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group
Sin intervención: Atraumatic extraction
Extraction with Periotomes and Luxators keeping the buccal plate of bone intact

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Buccal soft tissue contour
Periodo de tiempo: 12 Months
Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 4 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), 6 (T2), and 12 (T3) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T3) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.
12 Months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gingival Thickness
Periodo de tiempo: 12 Months
Gingival Thickness (GT) using Anesthetic Needle with a stopper (Paolantonio et al., 2002) will be measure at base line before extraction (T0), and during the follow up periods (T1-T3)
12 Months
Interdental Papilla height
Periodo de tiempo: 12 months
height of papilla fill
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Nourhan Gamal, Cairo University

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)

12 de marzo de 2020

Finalización primaria (Anticipado)

13 de marzo de 2021

Finalización del estudio (Anticipado)

1 de septiembre de 2021

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2020

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2020

Publicado por primera vez (Actual)

22 de julio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

20 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PER 632

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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 Alveolar Ridge Collapse

Ensayos clínicos sobre SubEpithelial connective graft

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