Treatment for advanced gum disease using chitosan products
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device With or Without a Chitosan Gel - a Randomized Parallel Arm Clinical Trial
This study is testing a new non-surgical treatment using chitosan products to see if it can help people with advanced gum disease who haven't improved with regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Labrida AS Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05773911 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a non-surgical treatment for advanced periodontal disease using a chitosan brush and chitosan gel. Patients who have not responded well to conventional treatments will receive mechanical debridement combined with the application of Labrida GeliX Chitosan gel. The primary objective is to measure the reduction in periodontal inflammation and attachment loss over a period of 6 to 12 months. The study will compare outcomes between a test group receiving the chitosan treatment and a control group.
Who should consider this trial
Good fit: Ideal candidates are patients with 3 to 8 teeth showing advanced periodontal attachment loss and specific clinical measurements indicating severe inflammation.
Not a fit: Patients with ongoing cancer treatments, poor oral hygiene, or other complicating dental conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced periodontal disease who have not benefited from traditional therapies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using adjunctive therapies for periodontal disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria:
Patients with at least 3 teeth but less than 8 teeth with advanced periodontal attachment loss.
Clinical Attachment Loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥5mm and ≤8 mm and inflammation as demonstrated by a modified Bleeding on Probing (BoP) grade 2 (line) or 3 ("spontaneous").
Exclusion criteria:
* Ongoing radiotherapy, ongoing chemotherapy, pregnant or nursing patients, prosthetic factors making access to clinical measurements impossible
* Poor oral hygiene with plaque at \>20% of the surfaces
* Periodontal pockets reaching to the apex of teeth.
* Teeth with active peri-apical pathology
* Teeth with root resorption as seen on radiographs
* Teeth with prosthodontic technical complications should be excluded or treated before inclusion (e.g., overhangs, open contacts with food impaction)
* Teeth with pockets from other reasons than periodontal disease
* Teeth with traumatic occlusion should be excluded or treated before inclusion (i.e., fremitus)
* Patients diagnosed with Periodontal disease grade C i.e., rapid rate of progression
* Sites in direct proximity with site(s) where patient places snuff (Copenhagen) will be excluded
Where this trial is running
Oslo
- Bjerke tannmedisin — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Johan C Wohlfahrt, PhD
- Email: casparwohlfahrt@gmail.com
- Phone: +4747905629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.