Soft Tissue Augmentation Around Dental Implants
18 maj 2026 uppdaterad av: Andrey Vasilyev
The Use of Collagen Matrices and Connective Tissue Grafts for Soft Tissue Augmentation Around Dental Implants
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
Studieöversikt
Status
Avslutad
Studietyp
Interventionell
Inskrivning (Faktisk)
84
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Moscow, Ryssland, 119021
- Central Research Institute of Dental and Maxillofacial Surgery
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Palate CTG
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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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.
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Experimentell: Tuberosity CTG
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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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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Experimentell: Fibro-Gide
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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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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Experimentell: FibroMatrix
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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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
Tidsram: Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
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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.
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Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2021
Primärt slutförande (Faktisk)
1 oktober 2024
Avslutad studie (Faktisk)
1 oktober 2024
Studieregistreringsdatum
Först inskickad
18 maj 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1/20
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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