Clinical trial NCT00639860: Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Official title: Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alveolar Bone Loss
Loss of Teeth Due to Extraction
Edentulous Alveolar Ridge
Keywords: extraction
implant
alveolar ridge preservation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: OraPharma
First posted: 2008-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

Detailed description: Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
* Residual extraction sockets must have \< 80% 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, hematological, 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, biphosphonatesm, medications affecting bone turnover, antibiotics for \> 7 days or any investigational drug
* Patients who are or become pregnant during the length of the study
* Sites in which one or both adjacent teeth are missing

Primary outcomes:
measure: Change in Bone Gain or Loss in Millimeters (Buccopalatal)
timeFrame: From Baseline to 12 weeks
measure: Change in Bone Gain or Loss in Millimeters (Mesiodistal)
timeFrame: From Baseline to 12 weeks
measure: Change in Bone Gain or Loss in Millimeters (Stent to Apex)
timeFrame: From Baseline to 12 weeks
measure: Radiographic Bone Changes
timeFrame: From Baseline to 12 weeks
measure: New Bone Formation
timeFrame: From Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: Professor
name: William V Giannobile, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69.