Connective Tissue Graft, Volume Collagen Matrix Xenograft
Conditions
Brief summary
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
DEVICEGeistlich 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.
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric dimensional changes | 0-5 years | To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical: PPD | 0-5 years | Clinical: Probing depth in neighboring teeth |
| Clinical BoP | 0-5 years | Clinical: Bleeding on probing |
| Clinical: Suppuration | 0-5 years | Clinical: Suppuration on probing |
| Clinical: Mucosa | 0-5 years | Clinical: Apical migration of the marginal mucosa |
| Clinical: ktw | 0-5 years | Clinical: Keratinized tissue width |
| Clinical: Mobility | 0-5 years | Clinical: Mobility |
| Clinical: Thickness | 0-5 years | Clinical: Mucosal thickness |
| Clinical: Contributing factors | 0-5 years | Clinical: Presence of local contributing factors |
| Patient-reported satisfaction | 0-5 years | Questionnaire: Overall patient satisfaction with the treatment provided |
| Patient-reported esthetics | 0-5 years | Questionnaire: Esthetics |
| Patient-reported discomfort | 0-5 years | Questionnaire: Discomfort |
| Patient-reported pain | 0-5 years | Questionnaire: Pain |
| Prosthetics Survival | 0-5 years | Prosthetic-related: Fixed dental prostheses survival rates |
| Prosthetics Success | 0-5 years | Prosthetic-related: Fixed dental prostheses success rates |
| Prosthetics Complications | 0-5 years | Prosthetic-related: Technical complications |
| Prosthetics PES-WES | 0-5 years | Prosthetic-related: Esthetic score (PES-WES) |
| Prosthetics: Occlusal | 0-5 years | Prosthetic-related: Occlusal contacts (static and dynamic) |
| Prosthetics: Interproximal | 0-5 years | Prosthetic-related: Presence of interproximal contacts. |
| Radiographics BL | 0-5 years | Marginal bone levels |
| Radiographics PP | 0-5 years | Periapical pathosis |
| Radiographics distance | 0-5 years | Distance from the adjacent teeth/implants |
| Radiographics Contacts | 0-5 years | Presence of open contacts |
Countries
Switzerland
Contacts
CONTACTManrique Fonseca, DDS
PRINCIPAL_INVESTIGATORManrique Fonseca, DDS
University of Bern
Outcome results
None listed