Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following … (NCT00639860) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
United States10 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Bone Gain or Loss in Millimeters (Buccopalatal)
Timeframe: From Baseline to 12 weeks
2
Change in Bone Gain or Loss in Millimeters (Mesiodistal)
Timeframe: From Baseline to 12 weeks
3
Change in Bone Gain or Loss in Millimeters (Stent to Apex)