BioXclude™ for Gum Disease

Not currently recruiting at 1 trial location
KF
CA
Overseen ByCharles A. Powell, DDS, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

Consent to be in the study
Non-emergent dental treatment
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
See 2 more

Exclusion Criteria

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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive scaling and root planing with or without the placement of dehydrated human amnion-chorion membrane (dHACM) in periodontal pockets

1 day
1 visit (in-person)

Follow-up

Participants are monitored for clinical attachment levels, pocket depths, and radiographic alveolar bone gain

9 months
Visits at Month 1, Month 3, Month 6, and Month 9

Long-term Follow-up

Participants continue to be monitored for clinical outcomes and receive periodontal maintenance

5 years
Visits at Year 3 and Year 5

What Are the Treatments Tested in This Trial?

Interventions

  • BioXclude™
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Deep Cleaning and InterventionExperimental Treatment1 Intervention
Group II: Deep Cleaning OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Citations

Investigating the Effects of Dehydrated Human Amnion ...These findings suggest that GFs contained in dHACM promote proliferation and migration of PDLCs and angiogenesis, which lead to enhanced periodontal healing.
BioXclude™ for Gum Disease · Info for ParticipantsBioXclude™ is unique because it is a membrane used in dental procedures to aid in tissue regeneration, which is different from other treatments like antibiotics ...
The improving effects of the amnion and chorion ...Reconstitution of the natural islet environment with biomaterials could improve tissue regeneration and periodontal disorder treatment.
Antimicrobial Activity of an Amnion-Chorion Membrane to ...The aim of this study was to evaluate wound biomodification by assessing antimicrobial properties present within a human-derived composite ...
Clinical and Histological Outcomes of Allogenic Amnion ...This study aims to compare an allogenic amnion chorion membrane (BioXclude®,. SNOASIS MEDICAL) to a collagen dressing (Collagen Patch®, Zimmer) ...
What is BioXcludeVERSATILE. The physical properties of BioXclude allow clinicians to avoid many of the draw- backs associated with traditional collagen and ...
evaluation of bioxclude amnion chorion membrane in the ...This relation makes the risk of maxillary sinus affection by any disease or surgical manipulation of maxillary teeth expected. The most common complication ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security