Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

Обзор

The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.

Вмешательства

• Устройство Geistlich Fibro-Gide®
  Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.

Первичные конечные точки

• Volumetric dimensional changes [Срок оценки: 0-5 years]

Вторичные конечные точки (12)

• Clinical: PPD [Срок оценки: 0-5 years]
• Clinical BoP [Срок оценки: 0-5 years]
• Clinical: Suppuration [Срок оценки: 0-5 years]
• Clinical: Mucosa [Срок оценки: 0-5 years]
• Clinical: ktw [Срок оценки: 0-5 years]
• Clinical: Mobility [Срок оценки: 0-5 years]
• Clinical: Thickness [Срок оценки: 0-5 years]
• Clinical: Contributing factors [Срок оценки: 0-5 years]
• Patient-reported satisfaction [Срок оценки: 0-5 years]
• Patient-reported esthetics [Срок оценки: 0-5 years]
• Patient-reported discomfort [Срок оценки: 0-5 years]
• Patient-reported pain [Срок оценки: 0-5 years]

Критерии участия

Критерии включения

• Informed Consent signed by the subject
• Age ≥ 18 years
• Willingness to sign informed consent and to participate in the study
• Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
• Tooth gap of ≥ 8 mm.
• Presence of natural or artificial opposing dentition
• Sufficient vertical interocclusal space of an implant restoration (7mm)
• Bounded by natural and periodontally stable teeth
• Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

Критерии исключения

• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
• Severe bruxism, clenching habits, or presence of oro-facial pain
• Uncontrolled diabetes mellitus (HbA1c >7.0)
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Severe hematologic disorders
• Any other diseases or medications that may compromise normal wound healing
• Pregnancy or nursing mother
• Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
• Vulnerable subjects
• Known or suspected non-compliance
• Drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University of Bern — Bern

Идентификаторы

NCT: NCT06335628 · RCT: CTG-VCMX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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