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BioXclude™ for Gum Disease

N/A
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 9, year 3, and year 5
Awards & highlights

Study Summary

This trial will compare the effectiveness of using a membrane to reduce pocket depth and improve attachment after scaling and root planing of teeth with periodontal disease.

Who is the study for?
This trial is for adults aged 18+ with moderate to severe chronic gum disease, having at least one tooth on each side of the mouth with specific levels of gum pocket depth. Participants should be in good or stable health (ASA Class I or II) and not pregnant, nursing, or have had recent periodontal therapy.Check my eligibility
What is being tested?
The study tests if adding a product called BioXclude™ (dHACM) to standard dental cleaning procedures can better reduce gum pocket depth and improve tooth attachment than cleaning alone. It's a comparison between mechanical scaling and root planing with and without dHACM.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort, swelling, infection risk increase at the treatment site due to the addition of dHACM during dental procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9, year 3, and year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9, year 3, and year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Attachment Levels
Pocket Depths
Radiographic Alveolar Bone Gain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Deep Cleaning and InterventionExperimental Treatment1 Intervention
One side of the participant's mouth will receive a deep cleaning in addition to the placement of a BioXclude™ membrane in the deep pocket sites. The participant will then be followed for 9 months with routine care.
Group II: Deep Cleaning OnlyActive Control1 Intervention
One side of the participant's mouth will receive deep cleaning (scaling and root planning) only. The participant will then be followed for 9 months with routine care.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,735 Previous Clinical Trials
2,148,921 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Addition of Dehydrated Human Amnion-Chorion Membrane During Scaling and Root Planing
2020. "Addition of Dehydrated Human Amnion-Chorion Membrane During Scaling and Root Planing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836378.
~57 spots leftby Apr 2025
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