About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.)
Trial design
Parallel
Treatments tested in this trial
Geistlich Fibro-Gide®
DeviceGeistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.
Treatment groups
Trial outcomes
Primary outcomes
Volumetric dimensional changes
To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX
Secondary outcomes
Clinical: PPD
Clinical: Probing depth in neighboring teeth
Clinical BoP
Clinical: Bleeding on probing
Clinical: Suppuration
Clinical: Suppuration on probing
Clinical: Mucosa
Clinical: Apical migration of the marginal mucosa
Sponsors and contacts
Click on the lead sponsor to view all of their trials.