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Effect of Collagen Membrane on Ridge Preservation

2 de junio de 2026 actualizado por: Debora Dias

Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.

Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.

The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.

Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.

Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.

During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.

The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

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

  • Nombre: Carla Sanchez, MS
  • Número de teléfono: 4126241179
  • Correo electrónico: cab28@pitt.edu

Copia de seguridad de contactos de estudio

  • Nombre: Debora R Dias, DDS, PhD
  • Número de teléfono: 4126488595
  • Correo electrónico: deboradias@pitt.edu

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
        • Contacto:
        • Investigador principal:
          • Debora R Dias, DDS, PhD
        • Contacto:
          • Debora R Dias, DDS, PhD
          • Número de teléfono: 412-648-8595
          • Correo electrónico: deboradias@pitt.edu

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 18-80
  • Indicated for extraction of a single-rooted maxillary tooth
  • ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
  • Presence of both adjacent teeth
  • No interproximal bone loss
  • ASA I-II health status
  • Ability to comply with required procedures, including attending required number of clinic visits

Exclusion Criteria:

  • Patients diagnosed with periodontitis adjacent to the area to be treated
  • History of allergic reactions to local anesthetics or bone graft material (self-reported);
  • Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
  • Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
  • Presence of active infectious diseases of any kind;
  • History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
  • Severe hematologic disorders (risk for hemorrhage)(self-reported);
  • Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
  • Any history of alcohol or drug abuse (self-reported);
  • Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control group (bone graft only)
Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.
Procedimiento: Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
Dispositivo: Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
Experimental: Test group (bone graft + collagen membrane)
Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.
Procedimiento: Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
Dispositivo: Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
Dispositivo: Resorbable collagen membrane (InterCollagen® Guide)
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Horizontal dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Horizontal dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Horizontal dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Volumetric dimensional changes (%)
Periodo de tiempo: Baseline and 4 months
Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
Baseline and 4 months
Mid-buccal soft tissue contour change (mm)
Periodo de tiempo: Baseline and 4 months
Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets. Adjacent teeth are used as reference for alignment. A positive value indicates soft tissue gain; a negative value indicates recession.
Baseline and 4 months
Mid-buccal soft tissue volume change (%)
Periodo de tiempo: Baseline and 4 months
Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage. Color-coded deviation maps will illustrate areas of soft tissue collapse or gain.
Baseline and 4 months
Interproximal papilla height change (mm)
Periodo de tiempo: Baseline and 4 months
Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline. A positive value indicates papilla gain; a negative value indicates papilla loss.
Baseline and 4 months
Wound healing (Wound Healing Index)
Periodo de tiempo: 1 week, 2 weeks, 1 month, 4 months
Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention). Lower scores indicate better healing.
1 week, 2 weeks, 1 month, 4 months
Incidence of postoperative complications (Percentage)
Periodo de tiempo: 1 week, 2 weeks, 1 month, 4 months
Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit. Complications will be recorded by a blinded clinical examiner at each scheduled visit.
1 week, 2 weeks, 1 month, 4 months
Postoperative pain
Periodo de tiempo: Day 1, Day 3, 1 week
Numeric scale (0-10) for pain after the extraction and ridge preservation procedure.
Day 1, Day 3, 1 week
Oral health-related quality of life (OHIP-14)
Periodo de tiempo: Baseline, 2 weeks, 4 months
Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire.
Baseline, 2 weeks, 4 months
Feasibility of prosthetically ideal implant placement without additional augmentation
Periodo de tiempo: 4 months
Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
4 months
Histological Outcomes
Periodo de tiempo: 4 months
In a subset of patients, a bone core biopsy will be obtained. Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement.
4 months
Patient satisfaction (VAS)
Periodo de tiempo: 4 months
Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
4 months

Colaboradores e Investigadores

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

Patrocinador

Debora Dias

Colaboradores

SigmaGraft Inc.

Investigadores

  • Investigador principal: Debora R Dias, DDS, PhD, University of Pittsburgh, Department of Periodontics and Preventive Dentistry

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

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)

26 de mayo de 2026

Finalización primaria (Estimado)

31 de octubre de 2027

Finalización del estudio (Estimado)

31 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

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

2 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY25080006

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 shared outside the primary research group due to concerns regarding participant privacy and confidentiality, as approved by the University of Pittsburgh Institutional Review Board.

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.

Sí

producto fabricado y exportado desde los 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. .

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