Alveolar Ridge Preservation Following Tooth Extraction.

Study Overview
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Brief Summary
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Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method. In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge? The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.

Detailed Description
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The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months. The following products will be used during the study: Collatape (Zimmer Dental)- approved by the FDA (class III) Cytoplast (Osteogenics Biomedical)- cleared by the FDA OssixPlus (Dantum Dental)- cleared by the FDA Renovix-Plus (Salvin)- cleared by the FDA BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking PuroⓇ, Zimmer Dental)- cleared by the FDA RegenerOssⓇ, Zimmer Dental) - cleared by the FDA During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following: % viable of bone % of connective tissue % of residual graft material

Official Title
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Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study

Conditions
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Tooth Fractures, Tooth Extraction Status Nos, Caries

Intervention / Treatment
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* Procedure: Tooth extraction and ridge preservation using different barrier mermbranes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must between the ages of 18 and 80. Subjects must require removal of at least one maxillary premolar Subjects should benefit from an implant-supported crown. Subjects must have voluntarily signed the informed consent form. Subjects must be assessed as ASA I, ASA II by a member of the research team. Exclusion Criteria: Medical conditions requiring the use of steroids. History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis. History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck. Subjects who have diabetes mellitus. Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study. Alcohol or drug abuse. Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco. Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Collatape (Zimmer Dental)<br>This material is a resorbable collagen wound dressing. They are made from bovine Achilles tendons and are a source of Type I collagen. The resorbable wound dressings are sterilized after purification with ethylene oxide. | Procedure: Tooth extraction and ridge preservation using different barrier mermbranes<br>* The hopeless and unrestorable teeth are planned for extraction and implant placement.<br>|
| Cytoplast Barrier Membranes TXT-200 Singles (Osteogenics Biomedical)<br>Cytoplast Barrier membranes are manufactured from high-density Polytetrafluoroethylene (PTFE) which allows them to withstand exposure to the oral environment. The textured surface increases the surface area available for cellular attachment during dental bone grafting procedures thereby aiding in stabilizing the PTFE membrane. It can be removed non-surgically after at least 21 days. | Procedure: Tooth extraction and ridge preservation using different barrier mermbranes<br>* The hopeless and unrestorable teeth are planned for extraction and implant placement.<br>|
| Ossix Plus (dantum dental)<br>OssixPlus is a resorbable collagen dental membrane used for Guided Bone Regeneration and Guided Tissue Regeneration. It contains a patented GLYMATRIX cross-linking technology that allows it to maintain barrier functionality for 4 to 6 months. The collagen is derived from porcine. | Procedure: Tooth extraction and ridge preservation using different barrier mermbranes<br>* The hopeless and unrestorable teeth are planned for extraction and implant placement.<br>|
| Renovix-Plus (Salvin)<br>Renovix Plus is a non-cross-linked extracellular matrix containing Type I, II, and III Collagen, Fibronectin, Laminin, and Elastin. It provides architecture and barrier protection for bone regeneration and soft tissue esthetics. This membrane resorbs within six months. | Procedure: Tooth extraction and ridge preservation using different barrier mermbranes<br>* The hopeless and unrestorable teeth are planned for extraction and implant placement.<br>|
| BioXclude (Snoasis)<br>BioXclude is a minimally manipulated allograft amnion chorion tissue. It is obtained from consenting mothers who donate their placentas after elective caesarian section delivery. The tissue is processed to cleanse and maintain the tissue. Following processing and dehydration, the allografts are packaged and terminally sterilized. | Procedure: Tooth extraction and ridge preservation using different barrier mermbranes<br>* The hopeless and unrestorable teeth are planned for extraction and implant placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge dimension changes before and after the augmentation. | The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction. | from the date of the extraction 4 months | 
| Histological Evaluation | A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen. | 4 months post-augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant site conditions | - Implant stability quotients as determined by resonance frequency analysis. | 4 months post-augmentation | 
| Implant site conditions | change of the periodontal phenotype | 4 months post-augmentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implant, alveolar ridge preservation