Clinical trial NCT02602223: Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
Official title: A Randomized Split-mouth Clinical Trial on Effectiveness of Amnion-Chorion Membranes in Alveolar Ridge Preservation: a Clinical, Radiological, & Morphometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alveolar Bone Loss
Pathological Conditions, Anatomical
Keywords: Alveolar Ridge Augmentation
Tooth Socket
Guided Tissue Regeneration
Membranes
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Snoasis Medical Products
First posted: 2015-11-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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. The hypotheses for the study is that the use of ACM in preservation of bone dimensions in extraction socket will result in greater remaining horizontal and vertical ridge dimension, and reduced postoperative discomfort when compared with D-PTFE in sites where extraction socket will not be closed by advancing the gums. Subjects in need of single rooted teeth extraction on both left and right side of the same jaw will be recruited. Pre-surgical clinical and radiological measurements will be made using dental calipers, stents and reduced cone beam computed tomography (CBCT) three dimensional scans. Involved teeth will be extracted with minimal trauma. Freeze dried bone allograft (bone from human donors) will be used in all extraction sockets. ACM will be used in the one extraction socket and D-PTFE in the other extraction socket without advancing the gums to cover the socket. A Visual Analog Score (VAS), pain scale questionnaire will be given to record the postoperative discomfort and patient will be seen for routine post-operative monitoring as well as research measurements. At 3-months recall postoperatively, clinical measurements and radiographic measurements will be recorded as before. Wound fluid will also be collected at all visits. The sites will be reentered and trephine core (bone sample) will be collected for histomorphometric as well as microtomographic assessment. Statistical analysis will be performed to test the significance using a mixed-model analysis of variance (ANOVA).

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).

Primary outcomes:
measure: Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures
timeFrame: 3-4 months
measure: Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.
timeFrame: 3-4 month
measure: Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.
timeFrame: 3-4 months
measure: Post Operative Pain
timeFrame: 0-2 weeks
measure: 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.
timeFrame: 3-4 months
measure: 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.
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health & Science University & Indiana University
name: Sivaraman Prakasam, BDS., MSD., PhD
role: PRINCIPAL_INVESTIGATOR
References: