The development of innovative solutions for dental and periodontal conditions marks a significant step forward in modern healthcare. Mastelli S.r.l and Clinical Research Technology S.r.l are sponsoring a new clinical trial evaluating the safety and performance of the medical device RDM36 alongside saline solution (NaCl 0.9%) therapy. This trial aims to address Black Triangles Syndrome (BTS) and periodontal gingival contraction, bringing hope and potential advancements to patients and clinicians. This study is listed as ‘Not yet recruiting,’ providing an opportunity for the clinical and regulatory community to collaborate.
In this article
- What is this clinical trial about?
- Who are the sponsors and what is RDM36?
- When will recruitment begin?
- FAQ
- What are the implications for professionals?
- Disclaimer
- Announcement link
What is this clinical trial about?
The clinical trial is designed to evaluate the performance and safety of the RDM36 medical device for the treatment of two dental and periodontal conditions: Black Triangles Syndrome (BTS) and periodontal gingival contraction. Black Triangles Syndrome refers to the appearance of small gaps between teeth near the gumline, often resulting from gum recession or other periodontal diseases. Gingival contraction, a condition affecting gum tissue elasticity, may exacerbate the appearance of these black triangular gaps.
Patients in the trial will undergo interventions including the use of the RDM36 device and saline solution (NaCl 0.9%) therapy. Determining the clinical efficacy and safety is a key objective of this study, ensuring compliance with medical device regulatory standards.
Who are the sponsors and what is RDM36?
The trial is sponsored by Mastelli S.r.l, an established healthcare company, and Clinical Research Technology S.r.l, which specializes in clinical trial processes. Together, they aim to leverage their expertise to establish key parameters for evaluating the RDM36’s effectiveness.
RDM36, the medical device under investigation, is specifically designed to address oral health issues such as BTS and gingival contraction. While detailed technical specifications of RDM36 are not provided in the source text, clinical teams anticipate the device incorporating optimized biocompatibility and functionality standards. Adherence to regulations like MDR Annex XIV remains central to this study.
When will recruitment begin?
As of the latest update, the study is marked as ‘Not yet recruiting.’ This status indicates preparation is underway, allowing time for ethical reviews, protocol finalization, and necessary certifications. Clinical and regulatory teams should watch this trial closely for updates on recruitment timelines and site activation.
Recruitment processes often determine the scope and pace of clinical trials, making it crucial for stakeholders to factor logistical readiness and team coordination.
FAQ
- What is Black Triangles Syndrome (BTS)?
Black Triangles Syndrome describes gaps or spaces between teeth near the gumline caused by gum recession, periodontal disease, or other dental issues. - What is RDM36?
RDM36 is a medical device developed for treating BTS and gingival contraction. Its specifications are tailored for addressing dental and periodontal health challenges. - What does ‘Not yet recruiting’ mean?
This status signifies that the clinical trial has not started enrolling participants yet, pending further preparation.
What are the implications for professionals?
This trial emphasizes the growing importance of innovative medical devices targeting dental and periodontal conditions. For clinical and regulatory teams, it represents a collaborative opportunity to define the path for new technologies in oral healthcare. Professionals must monitor developments to align device certification and clinical best practices with evolving evidence.
Furthermore, the outcomes of such trials serve not only to enhance patient solutions but also to refine compliance measures for device efficacy and safety, highlighting the importance of complete and thorough assessments.
Disclaimer
This article is informational and should not be considered legal or regulatory advice. Always consult professional guidelines specific to your country or organization.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07185191?term=medical+device