Actively Recruiting
Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial
Led by NMSI DENTMASTER · Updated on 2025-07-31
70
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Diagnosed with thin gingival phenotype (typically less than 1 mm thickness)
- Presence of malocclusion requiring correction in the mandibular incisors
- Sufficient number of teeth and bone support for orthodontic treatment
- Good periodontal health or controlled periodontitis
- No orthodontic treatment in the past 6 months
- Able to understand and provide informed consent
- Available for the full study duration and all follow-up visits
- Non-smoker or smokes fewer than 10 cigarettes per day
- Suitable radiographic evidence supporting malocclusion and bone/gingival assessment
You will not qualify if you...
- Active periodontal disease or significant periodontal bone loss contraindicating orthodontic treatment
- Contraindications to dental surgery or orthodontic treatment such as uncontrolled diabetes, bisphosphonate therapy, or history of radiation to the jaws
- Undergoing concurrent dental procedures that might affect orthodontic outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street
Novosibirsk, Novosibirsk Oblast, Russia, 630000
Actively Recruiting
Research Team
T
Tatiana Gatilova Tatyana Andreevna
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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