BioXclude™ for Gum Disease

Recruiting at 1 trial location

Overseen By Charles A. Powell, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antibiotics, Chronic therapy

Disqualifiers: Pregnancy, ASA Class III/IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

250 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment BioXclude™ for gum disease?

Research on a similar treatment using doxycycline hyclate, a component often used in periodontal treatments, shows it can significantly reduce gum pocket depth and improve gum attachment levels, which are key indicators of gum health. ^{1 2 3 4 5}

How does the treatment BioXclude™ for gum disease differ from other treatments?

BioXclude™ is unique because it is a membrane used in dental procedures to aid in tissue regeneration, which is different from other treatments like antibiotics or scaling and root planing that focus on reducing bacteria or cleaning the teeth. This approach is novel as it directly supports the healing and regeneration of gum tissues. ^{6 7 8 9 10}

What is the purpose of this trial?

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 after mechanical scaling and root planing. Specific Aim 1: to compare the clinical and radiographical outcome of using dehydrated human amnion-chorion membrane (dHACM) (commercially available as BioXclude®) with mechanical scaling and root planing.

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Deep Cleaning and Intervention Experimental Treatment 1 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 Only Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Systemic metronidazole in the treatment of periodontitis. [2019]

2. Thailand pubmed.ncbi.nlm.nih.gov

[Metronidazole: application in periodontal disease]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Disease progression in periodontally treated and untreated patients--a retrospective study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The use of locally delivered doxycycline in the treatment of periodontitis. Clinical results. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Incomplete adherence to an adjunctive systemic antibiotic regimen decreases clinical outcomes in generalized aggressive periodontitis patients: a pilot retrospective study. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Paraprobiotics in Non-Surgical Periodontal Therapy: Clinical and Microbiological Aspects in a 6-Month Follow-Up Domiciliary Protocol for Oral Hygiene. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of locally-delivered doxycycline microspheres in chronic localized periodontitis and on Porphyromonas gingivalis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of a multinutrient supplement as an adjunct to nonsurgical treatment of periodontitis: A randomized placebo-controlled clinical trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Novel 20% doxycycline-loaded PLGA nanospheres as adjunctive therapy in chronic periodontitis in type-2 diabetics: randomized clinical, immune and microbiological trial. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Monitoring the periodontal microbiota as an adjunct to periodontal therapy: rationale, interpretation of test results and application to patient management. [2017]