Phase 2 N=9 Randomized Single-blind Treatment

Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures

Alveolar Bone Loss · Pathological Conditions, Anatomical

Bottom Line

View on ClinicalTrials.gov: NCT02602223 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: 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 millimeters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placing Amnion chorion membrane over grafted site (Device); Placing d-PTFE membrane over grafted site (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jul 2014

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	—

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

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).

View full record on ClinicalTrials.gov →

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.