BioXclude™ for Gum Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for gum disease using a special membrane called BioXclude™. The study compares the effects of deep cleaning alone to deep cleaning combined with this membrane to determine if it leads to better gum health outcomes. Individuals with moderate to severe gum disease, affecting at least four teeth, might be suitable candidates. The goal is to assess whether adding the membrane can reduce gum pocket depth and improve attachment to the teeth. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future gum disease treatments.
Will I have to stop taking my current medications?
The trial requires that you have not been on chronic therapy with medications that could affect periodontal status or healing within 1 month prior to enrollment. If you are on such medications, you may need to stop taking them before joining the trial.
What prior data suggests that BioXclude™ is safe for treating gum disease?
Research shows that the BioXclude™ treatment, which uses a special membrane made from human tissue, is under study for its safety in treating gum disease. Previous patients have generally tolerated this membrane well, experiencing few problems or side effects during treatment.
Studies have found that the growth factors in the BioXclude membrane can aid gum healing by encouraging cell growth and blood vessel formation. This is promising because it can improve gum health without significant risks. Additionally, comparisons with other treatments, like collagen dressings, have found BioXclude to be safe.
While the current study lacks a specific phase, the use of BioXclude in other studies and treatments provides substantial safety information. This suggests that the treatment is likely safe and well-tolerated for most people. However, as with any medical treatment, discussing any concerns with healthcare providers is important.12345Why are researchers excited about this trial?
Researchers are excited about BioXclude™ for treating gum disease because it offers a unique approach compared to standard care options like scaling and root planing. Unlike traditional treatments that focus solely on cleaning, BioXclude™ involves placing a membrane in the deep pocket sites of the gums, which may help in tissue regeneration and healing. This membrane acts as a barrier, potentially promoting better and faster recovery of the gums by supporting the natural healing process. Such innovative features could lead to more effective management of gum disease, sparking interest and optimism in the dental community.
What evidence suggests that BioXclude™ might be an effective treatment for gum disease?
Research has shown that BioXclude™, a special membrane made from human tissue, can aid in healing gum disease. In this trial, one side of the participant's mouth will receive a deep cleaning along with the placement of a BioXclude™ membrane in the deep pocket sites. Studies indicate that this membrane contains growth factors that encourage cell growth and new blood vessel formation, enhancing gum healing. It also aids in tissue regeneration, crucial for treating gum disease. Additionally, BioXclude™ possesses antibacterial properties, helping to prevent infection and promote healthier gums. Overall, these findings support BioXclude™ as an effective option for improving dental health after deep cleaning procedures.12367
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive scaling and root planing with or without the placement of dehydrated human amnion-chorion membrane (dHACM) in periodontal pockets
Follow-up
Participants are monitored for clinical attachment levels, pocket depths, and radiographic alveolar bone gain
Long-term Follow-up
Participants continue to be monitored for clinical outcomes and receive periodontal maintenance
What Are the Treatments Tested in This Trial?
Interventions
- BioXclude™
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor