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The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.
The main questions it aims to answer:
Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?
Researchers will compare:
Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue
Participants will:
Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)
Attend clinic visits for follow-up examinations and assessments:
Undergo additional examinations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palate CTG | Experimental | Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume |
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| Tuberosity CTG | Experimental | Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume |
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| Fibro-Gide | Experimental | Xenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue |
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| FibroMatrix | Experimental | Xenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective Tissue Graft (Palate) | Procedure | Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin. Epithelium removed microscopically. Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures. Donor site closed with compression sutures. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation | The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge. Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software. Measurements are averaged across the three points per site. The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 6 months. | Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Institute of Dental and Maxillofacial Surgery | Moscow | 119021 | Russia |
Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) the single-center, academic nature of the study with a relatively small sample size, which increases re-identification risk even after de-identification; (2) the inclusion of detailed clinical, radiographic, and histological data that may contain sensitive personal health information; (3) ongoing secondary analyses and manuscript preparations by the investigative team; and (4) the absence of a dedicated infrastructure for secure, governed data sharing at this institution.
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| Connective Tissue Graft (Tuberosity) | Procedure | Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar. Epithelial strip removed. Graft placed and secured at the implant site using U-shaped suturing technique. Donor site closed with interrupted sutures. |
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| Fibro-Gide Collagen Matrix | Device | Porcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required. |
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| FibroMatrix Collagen Matrix | Device | Bovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required. |
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