Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement
Evaluation of Peri-implant Soft Tissue Thickness Following Augmentation Using Subepithelial Connective Tissue Graft Versus Submerged Tenting Abutment Versus Sub-crestal Implant Placement: A Randomized Controlled Clinical Trial
Peri-implant soft tissue thickness is an important determinant of the long-term stability and success of dental implants. Patients with a thin peri-implant soft tissue phenotype are at increased risk of soft tissue recession, marginal bone loss, and compromised esthetic and functional outcomes. Subepithelial connective tissue graft (SCTG) is considered the gold standard for soft tissue augmentation; however, it requires harvesting tissue from the palate, increasing surgical complexity, operative time, and postoperative morbidity. Less invasive approaches, including submerged tenting abutments and subcrestal implant placement, have been proposed as alternatives to improve peri-implant soft tissue dimensions while reducing patient morbidity, but direct comparative clinical evidence remains limited.
This investigator-initiated, single-center, randomized, parallel-group clinical trial will compare three approaches for peri-implant soft tissue augmentation in patients with a thin peri-implant soft tissue phenotype requiring a single dental implant in the posterior mandible. Eligible implant sites will be randomly assigned in a 1:1:1 allocation ratio to receive either subepithelial connective tissue grafting, submerged tenting abutment placement, or subcrestal implant placement during implant surgery.
The primary objective is to compare changes in peri-implant soft tissue thickness using three-dimensional digital intraoral scanning over a 12-month follow-up period. Secondary objectives include evaluation of keratinized tissue width, clinical soft tissue thickness, histological characteristics of peri-implant soft tissue, peri-implant crestal bone level changes, postoperative pain, operative time, patient-reported satisfaction, and postoperative complications. The results of this study are expected to provide evidence regarding whether minimally invasive treatment approaches can achieve clinical outcomes comparable to connective tissue grafting while reducing surgical morbidity and improving patient-centered outcomes.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Peri-implant soft tissue thickness is a critical factor influencing the biological stability, function, and long-term success of dental implant therapy. A thin peri-implant soft tissue phenotype has been associated with increased marginal bone remodeling, soft tissue recession, and compromised peri-implant tissue stability. Consequently, augmentation of peri-implant soft tissues has become an important component of implant treatment planning, particularly in patients with thin soft tissue phenotypes.
Subepithelial connective tissue grafting (SCTG) is widely regarded as the reference standard for peri-implant soft tissue augmentation because of its predictable ability to increase tissue volume and improve peri-implant tissue stability. Nevertheless, harvesting autogenous connective tissue from the palate increases operative time, donor-site morbidity, postoperative discomfort, and surgical complexity. These limitations have encouraged the development of less invasive techniques capable of enhancing peri-implant soft tissue dimensions while minimizing patient morbidity.
Submerged tenting abutments have recently been introduced as a minimally invasive method for maintaining soft tissue space during submerged healing following implant placement. By supporting the overlying soft tissues throughout the healing phase, these abutments may promote increased soft tissue thickness without the need for connective tissue harvesting. Although preliminary clinical reports have shown encouraging outcomes, direct comparisons with connective tissue grafting remain limited.
Subcrestal implant placement has also been proposed as an alternative method for improving peri-implant soft tissue dimensions. Positioning the implant platform approximately 2 mm below the alveolar crest may increase the vertical dimension of peri-implant soft tissues without requiring grafting procedures or additional prosthetic components. While this technique has demonstrated favorable biological behavior in previous studies, evidence directly comparing it with connective tissue grafting and submerged tenting abutments remains scarce.
Advances in digital intraoral scanning have enabled accurate, reproducible, and non-invasive three-dimensional assessment of peri-implant soft tissue changes over time. Digital volumetric analysis provides objective measurements while reducing operator-dependent variability associated with conventional clinical measurements. Combining digital assessment with clinical, radiographic, histological, and patient-reported outcomes provides a comprehensive evaluation of treatment effectiveness.
This investigator-initiated, single-center, randomized, parallel-group interventional clinical trial will enroll 33 implant sites in medically healthy adults requiring single implant placement in the posterior mandible and presenting with a thin peri-implant soft tissue phenotype (<2 mm). Implant sites will be randomly allocated in a 1:1:1 ratio to one of three intervention groups: (1) equicrestal implant placement with subepithelial connective tissue grafting, (2) equicrestal implant placement with a submerged tenting abutment, or (3) subcrestal implant placement without grafting or tenting abutment. Randomization will be performed using a computer-generated sequence with allocation concealment through opaque sealed envelopes. Outcome assessors and the biostatistician will remain blinded throughout data collection and analysis, whereas blinding of participants and the operating surgeon is not feasible because of the nature of the surgical interventions.
The primary outcome will be the change in peri-implant soft tissue thickness measured by standardized three-dimensional intraoral scanning and digital volumetric analysis. Secondary outcomes include histological characteristics of peri-implant soft tissues, clinical soft tissue thickness, width of keratinized mucosa, peri-implant crestal bone level changes assessed using standardized radiographs, postoperative pain measured using a visual analog scale (VAS), operative time, patient satisfaction measured using the Oral Health Impact Profile-14 (OHIP-14), and postoperative complications. Participants will be followed according to the predefined study schedule for 12 months after implant placement using standardized clinical, digital, radiographic, and patient-reported assessments.
The results of this study will provide high-quality comparative evidence regarding three contemporary approaches for peri-implant soft tissue augmentation. By evaluating volumetric, clinical, histological, radiographic, and patient-centered outcomes within the same randomized clinical trial, the study aims to identify treatment strategies that maximize peri-implant soft tissue stability while minimizing surgical morbidity. The findings may contribute to evidence-based decision-making for clinicians managing patients with thin peri-implant soft tissue phenotypes and support the development of less invasive treatment protocols for implant therapy.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Baraa M Nagy, BDS
- Número de telefone: +201063278917
- E-mail: baraa2480582@miuegypt.edu.eg
Estude backup de contato
- Nome: Zeinab H Abd El Rahman, PhD
- E-mail: zainab.hafez@miuegypt.edu.eg
Locais de estudo
-
-
-
Cairo, Egito
- Recrutamento
- Misr International University Dental Clinic Complex
-
Contato:
- Baraa M Nagy, BDS
- Número de telefone: +201063278917
- E-mail: baraa2480582@miuegypt.edu.eg
-
Contato:
- Zeinab H Abd El Rahman, PhD
- E-mail: zainab.hafez@miuegypt.edu.eg
-
Investigador principal:
- Hani E elnahass, Phd
-
Subinvestigador:
- zeinab h Abd El Rahman, Phd
-
Subinvestigador:
- Baraa m Nagy, BDS
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 20 years or older.
- Partially edentulous patients requiring a single dental implant in the posterior mandible.
- Thin peri-implant soft tissue phenotype (<2 mm).
- Horizontal alveolar ridge width of at least 6 mm.
- Vertical bone height of at least 10-12 mm, confirmed radiographically.
- Adequate interarch restorative space for implant-supported restoration.
- Medically healthy (American Society of Anesthesiologists [ASA] Physical Status I or II).
- Good oral hygiene.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Local pathological lesions affecting the surgical site.
- Smoking.
- Pregnancy or breastfeeding.
- Alcohol abuse or parafunctional habits that may compromise implant survival or wound healing.
- Medical or local conditions that could interfere with osseointegration, soft tissue healing, or study participation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Subepithelial Connective Tissue Graft (SCTG)
Participants assigned to this arm will receive equi-crestal dental implant placement followed by augmentation of the peri-implant soft tissue using an autogenous subepithelial connective tissue graft harvested from the palate.
The graft will be positioned over the implant site to increase peri-implant soft tissue thickness before primary flap closure.
|
Harvesting of an autogenous connective tissue graft from the palate and placement over an equicrestally positioned dental implant to augment peri-implant soft tissue thickness.
Outros nomes:
|
|
Experimental: Submerged Tenting Abutment
Participants assigned to this arm will receive equicrestal dental implant placement followed by placement of a submerged low-profile tenting healing abutment beneath the flap to support peri-implant soft tissue contour during healing without connective tissue grafting.
|
Placement of a submerged low-profile tenting healing abutment over an equicrestally positioned dental implant to support peri-implant soft tissue during healing.
|
|
Experimental: Subcrestal Implant Placement
Participants assigned to this arm will receive dental implant placement approximately 2 mm below the alveolar crest without connective tissue grafting or placement of a submerged tenting abutment.
|
Placement of a dental implant approximately 2 mm apical to the alveolar crest without soft tissue grafting or tenting abutment placement.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Peri-implant Soft Tissue Thickness
Prazo: Baseline, 3 months, 6 months, and 12 months after implant placement.
|
Change in peri-implant soft tissue thickness from baseline measured using three-dimensional digital intraoral scanning (Medit Intraoral Scanner) and digital volumetric analysis (Medit Design software).
Measurements will be performed by blinded outcome assessors and expressed in millimeters (mm).
|
Baseline, 3 months, 6 months, and 12 months after implant placement.
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Histological Characteristics of Peri-implant Soft Tissue
Prazo: 3 months
|
Histological evaluation of peri-implant soft tissue biopsy specimens obtained during second-stage implant surgery.
Tissue sections will be stained with hematoxylin and eosin and Masson's trichrome to assess epithelial thickness and collagen density.
|
3 months
|
|
Clinical Peri-implant Soft Tissue Thickness
Prazo: Baseline, 3 months, 6 months, and 12 months
|
Clinical measurement of peri-implant soft tissue thickness using standardized transgingival probing.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Peri-implant Crestal Bone Level Changes
Prazo: Baseline, 3 months, 6 months, and 12 months
|
Changes in peri-implant crestal bone level assessed using standardized periapical radiographs analyzed with ImageJ software.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Width of Keratinized Tissue
Prazo: Baseline, 3 months, 6 months, and 12 months
|
Clinical measurement of peri-implant keratinized tissue width using a standardized periodontal probe.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Postoperative Pain
Prazo: Daily during the first 10 postoperative days
|
Participant-reported postoperative pain measured using a 10-point Visual Analog Scale (VAS).
The scale ranges from 0 to 10, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = worst pain imaginable (very severe pain).
Higher scores indicate greater postoperative pain.
|
Daily during the first 10 postoperative days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Cadeira de estudo: Hani E elnahass, Phd, Professor, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
- Diretor de estudo: Zeinab E Abd El Rahman, Phd, Lecturer, Department of Oral Medicine, Faculty of Oral and Dental Medicine, Misr International University.
Publicações e links úteis
Publicações Gerais
- Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
- Thoma DS, Gasser TJW, Hammerle CHF, Strauss FJ, Jung RE. Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading. J Periodontol. 2023 Feb;94(2):230-243. doi: 10.1002/JPER.22-0226. Epub 2022 Oct 28.
- Lee CT, Tran D, Tsukiboshi Y, Min S, Kim SK, Ayilavarapu S, Weltman R. Clinical efficacy of soft-tissue augmentation on tissue preservation at immediate implant sites: A randomized controlled trial. J Clin Periodontol. 2023 Jul;50(7):1010-1020. doi: 10.1111/jcpe.13816. Epub 2023 Apr 13.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Teste controlado e aleatório
- Implante dentário
- Enxerto de tecido conjuntivo subepitelial
- Aumentação de tecidos moles
- Posicionamento do implante subcrestal
- Mandíbula posterior
- Peri-implant Soft Tissue
- Tenting Healing Abutment
- Digital Volumetric Analysis
- Submerged Tenting Abutment
- Thin Peri-implant Phenotype
- SCTG
- Digital Intraoral Scanner
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- PER3253019 (Outro identificador: Misr International University)
- MIU-IRB-2526-025 (Outro identificador: Misr International University Institutional Review Board)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .