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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Connective Tissue Graft (CTG) | No Intervention | Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-MagicĀ®. | |
| Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-GideĀ® | Experimental | The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geistlich Fibro-GideĀ® | Device | Geistlich Fibro-GideĀ® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric dimensional changes | To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX | 0-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical: PPD | Clinical: Probing depth in neighboring teeth | 0-5 years |
| Clinical BoP | Clinical: Bleeding on probing | 0-5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manrique Fonseca, DDS | Contact | +41316840630 | manrique.fonseca@unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Manrique Fonseca, DDS | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Recruiting | Bern | 3010 | Switzerland |
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| Clinical: Suppuration | Clinical: Suppuration on probing | 0-5 years |
| Clinical: Mucosa | Clinical: Apical migration of the marginal mucosa | 0-5 years |
| Clinical: ktw | Clinical: Keratinized tissue width | 0-5 years |
| Clinical: Mobility | Clinical: Mobility | 0-5 years |
| Clinical: Thickness | Clinical: Mucosal thickness | 0-5 years |
| Clinical: Contributing factors | Clinical: Presence of local contributing factors | 0-5 years |
| Patient-reported satisfaction | Questionnaire: Overall patient satisfaction with the treatment provided | 0-5 years |
| Patient-reported esthetics | Questionnaire: Esthetics | 0-5 years |
| Patient-reported discomfort | Questionnaire: Discomfort | 0-5 years |
| Patient-reported pain | Questionnaire: Pain | 0-5 years |
| Prosthetics Survival | Prosthetic-related: Fixed dental prostheses survival rates | 0-5 years |
| Prosthetics Success | Prosthetic-related: Fixed dental prostheses success rates | 0-5 years |
| Prosthetics Complications | Prosthetic-related: Technical complications | 0-5 years |
| Prosthetics PES-WES | Prosthetic-related: Esthetic score (PES-WES) | 0-5 years |
| Prosthetics: Occlusal | Prosthetic-related: Occlusal contacts (static and dynamic) | 0-5 years |
| Prosthetics: Interproximal | Prosthetic-related: Presence of interproximal contacts. | 0-5 years |
| Radiographics BL | Marginal bone levels | 0-5 years |
| Radiographics PP | Periapical pathosis | 0-5 years |
| Radiographics distance | Distance from the adjacent teeth/implants | 0-5 years |
| Radiographics Contacts | Presence of open contacts | 0-5 years |