Soft Tissue Augmentation Around Dental Implants
18. Mai 2026 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
84
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Moscow, Russland, 119021
- Central Research Institute of Dental and Maxillofacial Surgery
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2021
Primärer Abschluss (Tatsächlich)
1. Oktober 2024
Studienabschluss (Tatsächlich)
1. Oktober 2024
Studienanmeldedaten
Zuerst eingereicht
18. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2026
Zuerst gepostet (Tatsächlich)
22. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1/20
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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