Dental Implant Rehabilitation, Peri-implant Soft Tissue Augmentation
Conditions
Brief summary
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: * Before surgery * 3 months after surgery * 6 months after surgery Undergo additional examinations: * 3D intraoral scanning to assess changes in tissue volume * Cone-beam computed tomography (CBCT) to measure gum thickness * Polarized-light photography to evaluate gum color * Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition
Interventions
PROCEDUREConnective Tissue Graft (Palate)
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.
PROCEDUREConnective Tissue Graft (Tuberosity)
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.
DEVICEFibro-Gide Collagen Matrix
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.
DEVICEFibroMatrix Collagen Matrix
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.
Sponsors
Andrey Vasilyev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 21 and 75 years * Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth) * Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm * Signed voluntary informed consent for treatment and research participation * Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery * Adequate oral hygiene and commitment to maintain it throughout the study period
Exclusion criteria
* Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease) * Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids * History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment * Need for concurrent bone grafting or immediate implant placement following tooth extraction * Active periodontal disease or untreated oral infections at the time of surgery * Heavy smoking (\>10 cigarettes/day) or inability to abstain from smoking during the healing period * Pregnancy or lactation * Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics) * Participation in another clinical trial within 30 days prior to enrollment * Refusal to participate in any stage of the study or inability to comply with study procedures * Psychological or social conditions that, in the investigator's judgment, may compromise protocol adherence or data reliability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation | Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery | 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. |
Countries
Russia
Outcome results
None listed