RecruitingNot ApplicableNCT07097714

Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial


Sponsor

NMSI DENTMASTER

Enrollment

70 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Recent advances in orthodontic treatment have explored various materials to enhance treatment efficacy, particularly focusing on collagen scaffolds. Collagen, being a primary component of the bone matrix, has garnered attention for its biocompatibility, cell adhesion, and osteoconductivity properties. Studies have shown that collagen scaffolds undergo natural degradation, mimicking biological processes, and play a significant role in tissue engineering (International Journal of Implant Dentistry, 2023). This aligns with the growing interest in minimally invasive methods that accelerate orthodontic treatment and improve tissue regeneration. In this context, the application of collagen scaffolds, such as Ossix VOLUMAX, in conjunction with piezo-surgical decortication, presents a novel approach. This study aims to build upon the existing knowledge, exploring the efficacy of collagen scaffolds in enhancing orthodontic treatment outcomes, especially in patients with specific dental conditions like a thin gingival phenotype and malocclusion. The study\'s hypothesis is grounded in the promising properties of collagen-based materials in dental and orthodontic applications, as evidenced by recent research in the field.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) and a procedure called control for people with dental crowding, gingival recession, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPiezocision with ribose cross-linked collagen matrix (Ossix® Volumax)

A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be created in strategic locations to accelerate orthodontic tooth movement. The Ossix® Volumax collagen matrix will be trimmed and applied directly onto the decorticated bone surface to support bone regeneration and soft tissue augmentation.

PROCEDUREcontrol

A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement. The Deepitelized Free Gingival Graft (DFGG) will be placed and secured over the areas of decortication to promote soft tissue healing and augmentation.


Locations(1)

Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street

Novosibirsk, Novosibirsk Oblast, Russia

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NCT07097714


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