Status:
ACTIVE_NOT_RECRUITING
Addition of Dehydrated Human Amnion-Chorion Membrane During Scaling and Root Planing
Lead Sponsor:
University of Colorado, Denver
Conditions:
Periodontal Diseases
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Hypothesis: There will be an additional reduction of pocket depth and gain of clinical attachment when dehydrated human amnion-chorion membrane (dHACM) is placed into the periodontal disease defect af...
Detailed Description
The study product BioXclude™ is a commercially available Amnion-Chorion allograft membrane. BioXclude™ does not meet the criteria for FDA oversight as a drug, device or biologic and is regulated as a ...
Eligibility Criteria
Inclusion
- Stage III and IV periodontitis (generalized moderate to severe chronic periodontitis)
- At least 4 teeth (to include at least one qualifying tooth on the right and left side of the mouth) with probing depths of 6 to 9 millimeters and bleeding on probing
- at least 18 years of age
- consent to be in the study
- non-emergent dental treatment
- American Society of Anesthesiologists (ASA) Class I or II (prticipants that are systemically healthy or have a systemic condition that is well controlled and are able to receive elective dental care)
Exclusion
- \<18 years old or \>100 years old
- currently pregnant or within 6 months postpartum, nursing
- require antibiotic prophylaxis prior to dental procedures as outlined by the 2017 American Heart Association guidelines
- decisionally challenged adults
- ASA Class III or IV (patients that have non-controlled systemic conditions that are unable to have elective dental care)
- had periodontal therapy within 6 months of baseline treatment visit
- antibiotic therapy within 3 months prior to enrollment
- chronic therapy within 1 month prior to enrollment with medications that could affect periodontal status or healing
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03836378
Start Date
November 1 2020
End Date
November 1 2027
Last Update
April 5 2024
Active Locations (1)
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1
Sangeetha Chandrasekaran
Aurora, Colorado, United States, 80045