Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix) (Pontic-Essix)
31 de julio de 2026 actualizado por: University of Bern
Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial
This randomized controlled trial compares two provisional socket-sealing concepts following single non-molar tooth extraction and alveolar ridge preservation: a fixed, tooth-supported, 3D-printed ovate pontic provisional restoration providing active soft tissue support (test) versus a removable Essix-type provisional restoration without intentional soft tissue contact combined with a porcine collagen matrix seal (control).
Both groups receive alveolar ridge preservation using a deproteinized bovine bone mineral with 10% collagen.
The primary endpoint is interproximal soft tissue height at 5 months, adjusted for baseline, assessed by digital superimposition of intraoral surface scans.
Up to 40 participants will be enrolled at the University of Bern School of Dental Medicine.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Following tooth extraction, dimensional changes of the alveolar ridge and loss of interproximal soft tissue height may compromise esthetic and prosthetic outcomes. Alveolar ridge preservation attenuates hard tissue resorption but provides limited active support for the overlying soft tissues during healing. An ovate pontic provisional restoration may provide active soft tissue support and thereby help preserve interproximal soft tissue height. To date, no randomized controlled trial has compared a fixed ovate pontic provisional restoration with a removable non-contact Essix provisional restoration in the context of alveolar ridge preservation.
This is a single-center, open-label, confirmatory, randomized controlled trial with two parallel groups and 1:1 allocation. An adaptive design with an internal pilot phase (n=20) and blinded sample size re-estimation based on the residual variance of the primary endpoint is applied, up to a predefined maximum of 40 participants.
All participants undergo minimally traumatic, flapless single non-molar tooth extraction and alveolar ridge preservation with Bio-Oss Collagen. Test group: socket sealing by a fixed, 3D-printed ovate pontic provisional restoration providing active soft tissue support. Control group: socket sealing with Mucograft Seal plus a removable Essix-type provisional restoration positioned without intentional soft tissue contact.
Follow-up visits are performed at 2 weeks, 4 weeks, and 5 months. At baseline (T0) and at 5 months, intraoral surface scans, clinical photographs, cone-beam computed tomography, and patient-reported outcomes are collected. The between-group treatment effect on the primary endpoint is estimated using ANCOVA with the 5-month value as dependent variable, treatment group as fixed factor, and the baseline value as covariate; jaw is included as an additional between-subject factor.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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
- Nombre: Nicole Schenk, Dr. med. dent.
- Número de teléfono: +41 31 684 06 35
- Correo electrónico: nicole.schenk@unibe.ch
Copia de seguridad de contactos de estudio
- Nombre: Martin Schimmel, Prof. Dr. med. dent.
- Número de teléfono: +41 31 684 06 35
- Correo electrónico: martin.schimmel@unibe.ch
Ubicaciones de estudio
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Canton of Bern
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Bern, Canton of Bern, Suiza, 3010
- University of Bern, Department of Reconstructive Dentistry and Gerodontology
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Contacto:
- Nicole Schenk, Dr. med. dent.
- Número de teléfono: +41 31 684 06 35
- Correo electrónico: nicole.schenk@unibe.ch
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adults aged 18 years or older
- ASA physical status I or II
- Requiring a single non-molar tooth extraction (incisor, canine, or premolar) in the maxilla or mandible, with planned tooth replacement
- Extraction site bounded by natural, periodontally stable adjacent teeth
- Intact alveolar socket upon extraction, or no more than one bony wall (facial, palatal, or lingual) presenting a dehiscence extending less than 50% of the total bony wall height
- Willingness and ability to comply with the follow-up protocol
- Ability to give informed consent, as documented by signature
Exclusion Criteria:
- Current smokers, or former smokers who quit less than 6 months before extraction
- Uncontrolled diabetes mellitus (HbA1c > 7.0%)
- Clinical attachment loss ≥ 2 mm at the extraction site
- Active or recent chemotherapy, or history of head and neck radiotherapy
- Current or previous bisphosphonate therapy within the past 10 years
- Immunosuppressive medication
- Active oral or systemic acute infection
- Severe hematologic disorder, hepatic or renal failure, or any clinically relevant bleeding disorder or anticoagulant medication that cannot be safely managed for the planned surgical procedure
- Pregnancy or lactation
- Known allergy or hypersensitivity to any of the study materials, including bovine-derived bone substitute, porcine-derived collagen matrix, or collagen-containing biomaterials
- Any other disease or medication that may compromise normal wound healing
- Inability to follow the study procedures (e.g., insufficient language comprehension, cognitive impairment, psychological disorder, or dementia)
- Known or suspected non-compliance
- Participation in another clinical trial that may interfere with the present study
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Fixed ovate pontic provisional
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen.
Socket sealing is achieved by a fixed, 3D-printed provisional restoration incorporating an ovate pontic design that extends approximately 2 mm apical to the mucosal margin, providing active soft tissue support to maintain interproximal papilla height and facial soft tissue contour during healing.
The provisional is retained by adhesive bonding or temporary cementation on the adjacent teeth.
No additional collagen matrix or sutures are placed.
|
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland).
Used for alveolar ridge preservation by socket grafting after tooth extraction.
CE-marked and used within the approved indication.
Otros nombres:
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design.
Retained by adhesive bonding or temporary cementation on the adjacent teeth.
The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
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|
Comparador activo: Removable Essix provisional with collagen matrix seal
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen.
The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure.
A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.
|
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland).
Used for alveolar ridge preservation by socket grafting after tooth extraction.
CE-marked and used within the approved indication.
Otros nombres:
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design.
Retained by adhesive bonding or temporary cementation on the adjacent teeth.
The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
Patient-specific removable thermoplastic Essix-type appliance with an integrated artificial tooth.
The pontic is positioned above the mucosal level without intentional soft tissue contact.
Delivered at the surgical visit after socket sealing with the collagen matrix.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Interproximal soft tissue height at 5 months
Periodo de tiempo: Baseline (T0) and 5 months after tooth extraction
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Interproximal soft tissue height at 5 months, calculated per participant as the mean of the mesial and distal measurements and expressed in millimeters.
Measurements are obtained by digital superimposition of baseline and 5-month intraoral surface scans (Geomagic Control X, 3D Systems) by an independent, calibrated examiner.
The between-group treatment effect is estimated using ANCOVA with the 5-month value as the dependent variable, treatment group as a fixed factor, baseline value as a covariate, and jaw as an additional between-subject factor.
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Baseline (T0) and 5 months after tooth extraction
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Midfacial mucosal level at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
|
Vertical position of the midfacial mucosal margin at 5 months (mm), assessed on superimposed intraoral surface scans.
The between-group difference is estimated using ANCOVA with the 5-month value as dependent variable and the baseline value as covariate.
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Baseline (T0) and 5 months
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Horizontal ridge contour at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
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Horizontal ridge contour at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference, assessed on superimposed intraoral surface scans.
Baseline-adjusted analysis at each level.
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Baseline (T0) and 5 months
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Mucosal thickness at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
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Mucosal thickness at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference.
Baseline-adjusted analysis at each level
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Baseline (T0) and 5 months
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Volumetric soft tissue at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
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Volumetric soft tissue measurement at 5 months (mm3) within the defined region of interest, assessed on superimposed intraoral surface scans.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Alveolar hard tissue volume at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
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Volumetric measurement of alveolar hard tissue at 5 months (mm3), assessed on superimposed CBCT data.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Alveolar hard tissue contour at 5 months
Periodo de tiempo: Baseline (T0) and 5 months
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Linear measurement of alveolar hard tissue contour at 5 months (mm), assessed on superimposed CBCT data.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Postoperative discomfort (VAS)
Periodo de tiempo: 2 weeks and 4 weeks after tooth extraction
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Postoperative discomfort assessed on a 100-mm visual analogue scale, ranging from 0 mm (no discomfort) to 100 mm (worst imaginable discomfort).
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2 weeks and 4 weeks after tooth extraction
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Patient satisfaction with function (VAS)
Periodo de tiempo: 5 months
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Patient-rated satisfaction with the function of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
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5 months
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Patient satisfaction with esthetics (VAS)
Periodo de tiempo: 5 months
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Patient-rated satisfaction with the esthetics of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
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5 months
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Patient satisfaction with comfort (VAS)
Periodo de tiempo: 5 months
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Patient-rated satisfaction with the comfort of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
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5 months
|
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Overall treatment satisfaction (VAS)
Periodo de tiempo: 5 months
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Patient-rated overall satisfaction with the treatment received, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
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5 months
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Willingness to undergo the same procedure again (VAS)
Periodo de tiempo: 5 months
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Patient-rated willingness to undergo the same procedure again, assessed on a 100-mm visual analogue scale, ranging from 0 mm (definitely not) to 100 mm (definitely yes).
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5 months
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Oral Health Impact Profile (OHIP-G14)
Periodo de tiempo: Baseline (T0) and 5 months
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German version of the Oral Health Impact Profile, 14-item version.
Summary score range 0 to 56; higher scores indicate worse oral health-related quality of life.
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Baseline (T0) and 5 months
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Geriatric Oral Health Assessment Index (GOHAI)
Periodo de tiempo: Baseline (T0) and 5 months
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German version of the Geriatric Oral Health Assessment Index.
Summary score range 12 to 60; higher scores indicate better oral health-related quality of life.
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Baseline (T0) and 5 months
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Adverse events and provisional-related complications
Periodo de tiempo: Up to 5 months
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Occurrence and rate of adverse events, including postoperative infection, impaired wound healing, soft tissue dehiscence, loss or displacement of the bone substitute or collagen matrix, allergic or hypersensitivity reactions, pressure-induced mucosal lesions, debonding of the fixed provisional restoration, or irritation related to the Essix provisional.
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Up to 5 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nicole Schenk, Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
- Silla de estudio: Martin Schimmel, Prof. Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
- Director de estudio: Emilio Couso-Queiruga, PD Dr. med. dent., University of Bern, Department of Oral Surgery and Stomatology
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
- Couso-Queiruga E, Garaicoa-Pazmino C, Fonseca M, Chappuis V, Gonzalez-Martin O, Avila-Ortiz G. Interproximal Soft Tissue Height Changes After Unassisted Socket Healing vs Alveolar Ridge Preservation Therapy. Int J Periodontics Restorative Dent. 2024;44(5):520-533. doi: 10.11607/prd.6809.
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 (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de febrero de 2029
Finalización del estudio (Estimado)
1 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pontic-Essix
- 2026-01626 (Otro identificador: Swiss Ethics Committee (BASEC))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be publicly shared.
The informed consent and data protection framework of this trial do not provide for unrestricted public sharing of coded participant-level data.
Aggregated study results will be published in a peer-reviewed journal and posted in the Swiss National Clinical Trials Portal (SNCTP) and on ClinicalTrials.gov in accordance with ClinO Art.
65a.
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. .