Soft Tissue Augmentation Around Dental Implants
18 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Concluído
Tipo de estudo
Intervencional
Inscrição (Real)
84
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Moscow, Rússia, 119021
- Central Research Institute of Dental and Maxillofacial Surgery
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de outubro de 2021
Conclusão Primária (Real)
1 de outubro de 2024
Conclusão do estudo (Real)
1 de outubro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
22 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 1/20
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .