Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 groups that differ only in the material that will be used at the graft site:
- Gum tissue taken from the patient's own palate (standard of care group)
- Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study).
Both materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study.
Participants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate (standard of care) or commercially available tissue called a "collagen matrix" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.
Teeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing/flossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. "Gum grafting" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Angela Palaiologou-Gallis, DDS
- Número de telefone: 210-567-3567
- E-mail: palaiologouA@uthscsa.edu
Estude backup de contato
- Nome: Brian L Mealey, DDS, MS
- Número de telefone: 210-567-3589
- E-mail: mealey@uthscsa.edu
Locais de estudo
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center at San Antonio School of Dentistry
-
Contato:
- Brian L Mealey, DDS, MS
- Número de telefone: 210-567-3318
- E-mail: mealey@uthscsa.edu
-
Contato:
- Angela Palaiologou-Gallis, DDS
- Número de telefone: 210-567-3589
- E-mail: palaiologouA@uthscsa.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female patient aged 18 to 89
- One or more teeth/dental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT
- A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.
- Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day).
Exclusion Criteria:
- Patients with a known allergy to collagen of animal origins.
- Patients who will not cooperate with the follow-up schedule.
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)
- Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- Patients with active or systemic infections other than periodontitis; a disease entity, condition or therapeutic regimen which decreases probability of soft tissue healing, e.g., poorly controlled diabetes, autoimmune diseases, long-term steroid therapy.
- Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)
- People who live more than 50 miles from the UTSA School of Dentistry are not eligible.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Test Group Porcine Collagen Matrix
The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
|
The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
|
|
Sem intervenção: Control Group - Palatal Graft
The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in width of Keratinized Tissue
Prazo: Baseline to 6 months
|
The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.
|
Baseline to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Graft dimension width change
Prazo: Baseline to 6 months
|
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)
|
Baseline to 6 months
|
|
Graft Length Change
Prazo: Baseline to 6 months
|
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft length (horizontal dimension).
|
Baseline to 6 months
|
|
Dimensional area change
Prazo: Baseline to 6 months
|
Dimensional change of the grafted area during healing will be assessed by endpoints of graft width (vertical dimension), graft length (horizontal dimension) to measure graft area.
|
Baseline to 6 months
|
|
Length of surgery in minutes
Prazo: Time to complete surgery (approximately 2-3 hours)
|
The length of surgery in minutes will be assessed by use of a standard timer.
The timer will start when the first incision is made.
The timer will stop 3 minutes after the final suture is placed and pressure has been applied at the recipient surgery site.
|
Time to complete surgery (approximately 2-3 hours)
|
|
Numerical rating score for color match
Prazo: One month to 6 months
|
A 21-point numerical rating scale (NRS-21) with which patients and clinicians can assess color match of the grafted area to the surrounding soft tissue.
The NRS-21 scale allows scores ranging from 0 (worst color match) to 10 (best color match) in increments of 0.5.
|
One month to 6 months
|
|
Pain Score on Numeric Rating Scale (NRS)
Prazo: 24 to 168 hours after surgery
|
Pain associated with the surgery will be assessed by patients using NRS-21 that ranges from 0 to 10 in 0.5 increments, with 0 indicating no pain and 10 indicating intolerable pain.
Patients will record NRS-21 scores on paper forms
|
24 to 168 hours after surgery
|
|
Analgesic consumption
Prazo: 24 to 168 hours
|
Participants will count and document number of analgesics (ibuprofen and acetaminophen) taken after surgery
|
24 to 168 hours
|
|
San Antonio Texture index (SaTi)
Prazo: One month to six months
|
A 4-point texture index score for clinicians to assess the tissue texture match of the grafted area to the surrounding soft tissue. The SATi is a four-point rating scale as follows:
|
One month to six months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Brian L Mealey, DDS, MS, The University of Texas Health Science Center at San Antonio
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00002814
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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
produto fabricado e exportado 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 .