Clinical trials are done to investigate if the treatment is efficient and safe, to improve the health and quality of the life for patients. In this article, we present you clinical trials with chitosan-based products which are about to be performed and two completed clinical trials about dental implant maintenance and chitosan nerve tubes.
Currently, there are 10 chitosan-related clinical studies registered at clinicaltrials.gov with current status “recruiting” or “not yet recruiting” (visited on 23.03.20). The table below lists those clinical studies with title, the corresponding condition, what kind of intervention is planned and where the clinical studies are going to be conducted.
|1||Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds||Diabetic Foot Ulcer||Device: ChitoCare gel
Device: Placebo gel
|2||Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer||Clinical Decision-Making
Early Detection of Cancer
|3||Safety Performance chitcsan osteoarthritis Viscosuppl Ementation||Knee Osteoarthritis||Device: Investigational device coded KIO014
Device: Durolane(r) as control device
|Not yet recruting|
|4||Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients||Prostate Cancer||Drug: Chitosan||Recruting||United States|
|5||Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone||Periodontal Diseases||Device: Labrida Bioclean
Device: Gracey Periodontal curettes
|6||Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device||Peri-Implantitis||Device: Labrida BioClean
Other: Titanium curettes
|7||Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal||Postoperative Pain||Drug: chitosan nanoparticles
Drug: Sodium Hypochlorite
|Not yet recruting|
|8||The Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis||Atopic Dermatitis||Device: DermaCura® Chitosan based antimicrobial therapeutic clothing
Device: Binamed® silver based antimicrobial therapeutic clothing
Device: Binamed® therapeutic clothing without antimicrobial agents
|9||Antimicrobial Efficacy of Four Different Irrigation Protocols||Dental Pulp Necrosis||Procedure: irrigation||Not yet recruting||Egypt|
|10||Dentures Biofilm and Artificial Biofilm Substitute||Biofilm||Other: 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.||Recruting||Germany|
Another 40 studies have been completed in recent years, including 7 in the United States and China, respectively, and 11 in Europe. In our 'Clinical Studies' section, we will inform you about further results in the coming months. Do you need chitosans for your clinical trial? Contact us - we are happy to assist you in finding the right GMP chitosan.
In the following we present the results of two clinical studies in the dental field and the topic of healing nerve injuries.
Treatment of peri-implant mucositis with a chitosan brush – a pilot randomized clinical trial
Wohlfahrt J. C., Aass A. M., Koldsland O. C., Int. J. Dent. Hyg., 17 (2), 170-176, May 2019, DOI: 10.1111/idh.12381
Inflammation of the mucous membrane surrounding the neck of a dental implant is called peri-implant mucositis. Damage to the hard tissue surrounding the implant during e.g. surgical procedures can lead to peri-implant mucositis and later to peri-implantitis. Peri-implantitis is triggered by a wide variety of germs and leads to bone loss. Similar in periodontitis, plaque deposits on the implant causing inflammation. If peri-implant mucositis is present, daily oral hygiene and regular professional maintenance of the dental implants are important to prevent peri-implantitis. Dental debridement is a method were the implant surface is mechanically cleaned, for example with a curette.
The presented study compared debridement with a titanium curette to debridement with a chitosan brush. The techniques were examined with regard to their effectiveness in preventing peri-implant inflammation of the implant. The fibers of the brush were made of chitosan, a bacteriostatic and biocompatible polymer which could have a positive effect on the treatment. If chitosan fibers remain in the peri-implant pocket after treatment, no damage is caused due to its biodegradability or even might have a positive effect. The study was conducted at the University of Oslo over a period of 6 months. The participants had at least two implants which had been in place for more than 12 months. Criteria were an developed peri-implant mucositis with a pocket probing depth (PPD) of at least 4 mm and a positive bleeding on probing score (mBOP), but no peri-implant bone loss visible in radiography. Clinical examinations were carried out at beginning (baseline), after two, four and 24 weeks by two periodontists. The implants were randomized, and treatment was performed at beginning of the study with a titanium cuvette or with a chitosan brush (BioClean, LABRIDA AS, Oslo Norway) using an oscillating handpiece. Supportive treatment was performed after 3 months. 11 patients with 24 implants in total participated in the study.
- Significant reductions in mBoP for both groups after 6 month
- Chitosan brush group had better improvements in mBoP at week 2 and 4 in comparison to the titanium group
- Significant reduction in PPD at week 4 for chitosan brush group
- Stable bone levels in both groups
Conclusion: Both methods of debridement of the implants significantly reduced clinical signs of inflammation at 6 months after treatment and 3 month after supportive treatment. The results suggest that debridement with a chitosan brush is efficient and safe. The next step is to confirm results in a randomized multicenter clinical trial.
Enhancing the outcome of traumatic sensory nerve lesions of the hand by additional use of a chitosan nerve tube in primary nerve repair: A randomized controlled bicentric trial
Neubrech F., Sauerbier M., Moll W., Seegmüller J., Heider S., Harhaus L., Bickert B., Kneser U., Kremer T., Plastic and reconstructive surgery, 142 (2), 415-424, Aug 2018, DOI: 10.1097/PRS.0000000000004574
Injury of peripheral sensory nerves is a common challenge in acute hand injuries. The usual treatment here is a microsurgical surgical technique in which an end-to-end adaptation of the nerve stumps is carried out. Typical consequences of unsuccessful surgery can be permanent loss of sensitivity or the formation of painful neuromas. Neuromas are knot formations that arise at the previous point in the severing of the peripheral nerve.
In the study, the authors investigated whether the additional use of a chitosan nerve tube for primary nerve repair has a positive effect on sensory recovery. The resorbable chitosan tube is designed to coat and protect the repaired nerve lesion and to prevent neuroma formation. Previous studies have shown that chitosan has a positive effect on the survival and orientation of Schwann cells, as well as on the differentiation of neuronal cells. In order to demonstrate the positive effect of the additional use of a chitosan nerve tube compared to microsurgical nerve repair alone, a randomized, controlled study with a parallel group design and double-blind evaluation was carried out at two study centers. The most important test parameter was the two-point discrimination threshold after 6 months (sensory recovery). In this test, the patient touches two needle tips, which are located at different distances from each other. The threshold is reached when the two needle tips can no longer be perceived separately. Other result parameters included the Semmes-Weinstein monofilament test (sensitivity test), pain, neuroma development and the limitations of arm, shoulder and hand mobility using a score system. In total 74 patients were enrolled in the study.
- Higher static two-point discrimination and sensitivity (Semmes-Weinstein monofilament test) in the group with chitosan nerve tubes
- Average two-point discrimination was 6.3 mm in the chitosan group and 8 mm in the control group
- 3 neuromas were found in control group
- No neuromas were found in the chitosan group
Conclusion: The results suggest that regeneration after peripheral nerve injury can be improved by application of chitosan nerve tubes in repair surgery. Further studies need to confirm those findings.