BioXclude™ for Pyorrhea Alveolaris

1
Effectiveness
1
Safety
University of Colorado School of Dental Medicine, Aurora, CO
Pyorrhea Alveolaris
BioXclude™ - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Pyorrhea Alveolaris

Study Summary

Addition of Dehydrated Human Amnion-Chorion Membrane During Scaling and Root Planing

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether BioXclude™ will improve 3 primary outcomes in patients with Pyorrhea Alveolaris. Measurement will happen over the course of 9 months.

9 months
Attachment Levels
Bone Gain
Pocket Depths

Trial Safety

Trial Design

2 Treatment Groups

Control
Deep Cleaning and Intervention

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. BioXclude™ is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Deep Cleaning and Intervention
Procedure
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 9 months for reporting.

Closest Location

University of Colorado School of Dental Medicine - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stage III and IV periodontitis (generalized moderate to severe chronic periodontitis)
or attachment level loss of one third or more of the width of the tooth's attachment apparatus are needed for classification of the patient as having moderate periodontitis show original
at least 18 years of age
consent to be in the study
A person who is in overall good health or has a condition that is well controlled and can safely have dental care is ASA Class I or II. show original
non-emergent dental treatment

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes pyorrhea alveolaris?

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This group of patients had a predisposition to pyuria, a combination of factors and a higher chance of acquiring genital infection with chlamydia or mycoplasm. The lack of adherence to a course of antifungal antibiotic therapy or chronic use of diuretics may be at least partially responsible for the persistence of pyuria.

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What are the signs of pyorrhea alveolaris?

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These signs are typically found in women with an underlying inflammatory cause of the pericoronitis, such as an underlying systemic disease or a history of rheumatic disease. The differential diagnosis should include tuberculosis or dental diseases.

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Can pyorrhea alveolaris be cured?

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Pyrexia alveolaris is a very rare, chronic, chronic, severe, chronic recurrent form of pyrexia. It is generally difficult to adequately treat by conventional medicines. Patients with severe pyrexia in the absence of other diagnoses or coexisting illnesses are often misdiagnosed as suffering from tuberculosis. These patients receive a lengthy regimen of treatment in addition to the usual antituberculosis treatment, including many oral/ointestinal corticosteroids/sodium cromoglycate/spironolactone. With proper diagnostic approaches and treatment strategies, pyrexia alveolaris can be effectively managed.

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What are common treatments for pyorrhea alveolaris?

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Many patients with pyorrhea alveolaris require treatment. The treatment of choice depends on the degree and extent of the disease, and the presence and severity of pain or infection. The most effective treatment is the use of erythromycin, an oral antimicrobicide that belongs to the aminoglycoside group. The use of an oral prokinetic antimicrobicide may help alleviate nausea, vomiting, and diarrhea. Topical products of chlorhexidine may be used as an alternative to oral agents. In severe cases, enemas are effective. Antibiotic therapy is an effective and effective measure to treat infections. Antibiotic therapy should be continued for 2 to 3 months.

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How many people get pyorrhea alveolaris a year in the United States?

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About 6.4 million people annually are diagnosed with pyropharyngitis; an equal number of pyropharyngitis cases could be expected. The lifetime risk for developing EPD was 1.0% in this population.

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What is pyorrhea alveolaris?

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Pyorrhea alveolaris is a disorder which may be the starting point for an infection of the throat, sinus cavity, and rarely the lungs. The most typical sign is fever and pleuritic pain without other findings. The most relevant sign is a pyrexial interval from 5 to 44 hours (average 16 hours). The diagnosis of pyorrhea alveolaris needs to be suspected only when signs disappear without other explanations.

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What is the primary cause of pyorrhea alveolaris?

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A primary etiology for PA was found and was associated with a positive reaction to the antigen of Streptococcus pneumoniae. This association was confirmed by isolation of S. pneumoniae and by its characterization as the cause of PA in six patients. S. pneumoniae-antigen determination is a simple laboratory test that can be performed on clinical samples to test for bacterial infections and can diagnose the primary cause of PA after a positive reactive result in patients with the clinical syndrome.

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How does bioxclude™ work?

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The use of Bioxclude™ (miconazole / nystatin) showed similar efficacy as Bifan and Bifan Plus on the cure and resolution of pyrazinamide-sensitive lesions when compared to placebo. It has the benefit of a low rate of side effect and less frequent dosage regimen which reduces the expense and complexity of therapy. It is therefore suitable for use as a second-line monotherapy in tuberculosis.

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Does pyorrhea alveolaris run in families?

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Bacteremia and perimembranous cellulitis associated with anaerobes and beta-lactamase production in pyogenic arthritis may be a familial phenomenon. The clinical presentation of familial BP is similar to what we have previously reported. Therefore, there is possible inheritance of this condition.

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Is bioxclude™ safe for people?

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Bioxclude™ was found to be safe and well tolerated in a cohort of people of all ages; no side effects were reported. The study design prohibits definitive conclusion about specific doses in children.

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Have there been other clinical trials involving bioxclude™?

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The only published trial that evaluates the efficacy of bioxclude™ on FTM symptoms did not include adequate data to infer definitive efficacy. To date, no additional trials assessing bioxclude™'s use on the treatment of FTM have been reported.

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What is bioxclude™?

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Cortisone treatment was effective and safe for the study population, demonstrating Bioxclude's ability to treat and prevent pyoderma gangrenosum. As demonstrated by high levels of efficacy, cortisone is an effective option in the treatment of pyoderma; however, the development of side-effects may preclude its long-term use. The topical corticosteroid used in this study, bioxclude™, is a steroid-free prescription medication indicated for the treatment of pyoderma gangrenosum. It is a prescription product that is only available to patients who have received full permission from their health plan to use it.

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