Phase 2
Completed N=9
Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
Alveolar Bone Loss · Pathological Conditions, Anatomical
Source: ClinicalTrials.gov NCT02602223 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures — 2.54; 2.72 millimeters
Summary
The purpose of this study is to examine if a biologically active commercially available amnion chorion membrane (ACM) is as effective as the commercially available inert dense polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it provides the added benefit of reducing post-operative discomfort after dental surgery
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures |
2.54; 2.72 | — |
| PRIMARY Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages. |
51.74; 37.31 | — |
| PRIMARY Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages. |
8.31; 3.50 | — |
| PRIMARY Post Operative Pain |
1.82; 4.09 | — |
| PRIMARY Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans. |
1.33; 2.53 | — |
| PRIMARY Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans. |
-0.24; 1.18 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects needing bilateral non-molar dental extractions in the same arch and consenting to a 2nd surgery for core-biopsy participated in the study. Subjects were required to be within the American Academy of Anesthesiologists (ASA) classifications ASA I or ASA II. Males between 18-75 years and females between 18-50 years of age were screened.
Exclusion Criteria
- inability or anticipated failure to maintain adequate oral hygiene; evidence of active periodontitis; pregnant or breastfeeding mothers, unstable systemic diseases or with compromised immune system (e.g., uncontrolled diabetes, etc.) or unstable bleeding disorders; active infectious diseases (e.g., hepatitis, tuberculosis, HIV, etc.); mental disabilities that may hinder participation; active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity within last 6-months; conditions/medications contraindicated for bone regeneration (e.g., methotrexate, steroids, bisphosphonates, cyclosporin-A), and and self-reported tobacco usage (equivalent to >20 cigarettes per day).
Data sourced from ClinicalTrials.gov (NCT02602223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.