Recruiting NCT06335628
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Geistlich Fibro-Gide®.
- Who it may be relevant to
- Registry conditions: Connective Tissue Graft, Volume Collagen Matrix Xenograft. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Volumetric dimensional changes [Time frame: 0-5 years]
Secondary outcome measures (12)
- Clinical: PPD [Time frame: 0-5 years]
- Clinical BoP [Time frame: 0-5 years]
- Clinical: Suppuration [Time frame: 0-5 years]
- Clinical: Mucosa [Time frame: 0-5 years]
- Clinical: ktw [Time frame: 0-5 years]
- Clinical: Mobility [Time frame: 0-5 years]
- Clinical: Thickness [Time frame: 0-5 years]
- Clinical: Contributing factors [Time frame: 0-5 years]
- Patient-reported satisfaction [Time frame: 0-5 years]
- Patient-reported esthetics [Time frame: 0-5 years]
- Patient-reported discomfort [Time frame: 0-5 years]
- Patient-reported pain [Time frame: 0-5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University of Bern — Bern
Identifiers
NCT: NCT06335628 · RCT: CTG-VCMX