Dental Implant Clinical Trial
Official title:
Clinical and Histological Evaluation of Zimmer Puros® Allograft vs. Creos™ (Low-cost) Allograft for Alveolar Ridge Preservation Following Exodontia
Verified date | March 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel Biocare,), a low-cost allograft material, 90 days following exodontia.
Status | Completed |
Enrollment | 15 |
Est. completion date | October 1, 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Systemically healthy subjects with two non-adjacent molar or premolar teeth located in the same jaw that require extraction and socket augmentation for implant site development (treatment sites may be located in either the mandibular or maxillary jaw) - Residual extraction sockets must have <70% bone loss in all dimensions (3 or 4-walled bony defects) - Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate) - Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments - Subjects who read, understand and are willing to sign an informed consent statement. Exclusion Criteria: - Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site - Presence of acute infections at the time of tooth extraction - Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other renal, hepatic, cardiac, endocrine, hematologic, autoimmune or acute infectious diseases that makes interpretation of the data more difficult - History of head & neck radiation therapy - Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug - Patients who are or become pregnant during the length of the study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida College of Dentistry-Periodontics | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone change in millimeters from initial (baseline) to full healing (week 12) | At week 12 | ||
Primary | Cone beam computed tomography bone density changes | At week 12 | ||
Primary | Percentage of bone formation in the alveolar bone core biopsies | At week 12 | ||
Primary | Percentage of volumetric bone formation observed by comparison of Cone beam computed tomography images and the percentage of residual Puros® bone cores | At week 12 | ||
Primary | Percentage of volumetric bone formation observed by comparison of Cone beam computed tomography images and the percentage of residual creos™ allograft in the bone cores | At week 12 | ||
Secondary | Facial/buccal alveolar bone thickness measured in millimeters with calipers | After extraction of the tooth, the facial/buccal bone thickness will be measured with calipers to the nearest millimeter. | At Baseline | |
Secondary | Length of alveolar dehiscence defects measured in millimeters with a periodontal probe | This measurement is made after the tooth is extracted and measured with a periodontal probe to the nearest millimeter | At Baseline | |
Secondary | Width of alveolar dehiscence defects measured in millimeters with a periodontal probe | This measurement is made after the tooth is extracted and measured with a periodontal probe to the nearest millimeter | At Baseline | |
Secondary | Plaque score | A disclosing solution such is painted on all exposed tooth surfaces. After the patient has rinsed, the operator (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction. When found, they are recorded by making a dash/red color in the appropriate spaces on the record form. Those surfaces, which do not have soft accumulations at the dentogingival junction, are not recorded. | Pre-op, Baseline, Week 2, 8 and 12 | |
Secondary | Subjective clinical bone density on re-entry | Assessed during osteotomy for implant placement | At week 12 |
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