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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of a collagen scaffold called Ossix VOLUMAX combined with piezo-surgical decortication to improve orthodontic treatment outcomes. This study focuses on adults with a thin gingival phenotype and malocclusion, especially in the lower front teeth. The goal is to see if this new approach can increase gingival thickness and bone volume, reduce surgery risks, and shorten treatment time better than current methods. Participants are divided into two groups: one receives piezocision with the collagen scaffold, and the other receives piezocision with a deepithelialized free gingival graft (DFGG). The piezocision involves creating precise vertical grooves in the alveolar bone to help tooth movement. The collagen scaffold is applied directly to the bone to support tissue regeneration, while the control group receives a graft from the palate as a standard treatment. Throughout the study, participants undergo regular evaluations including measurements of gingival thickness and bone volume before surgery and at 1 month, 6 months, and 1 year after. Other assessments include risk of gum recession, surgery duration, orthodontic treatment time, and patient satisfaction using surveys. The study includes follow-up visits to monitor outcomes and ensure safety, with all assessments done by blinded examiners to maintain objectivity.
CONDITIONS
Brief 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 a thin gingival phenotype (typically gingival thickness less than 1 mm)
- Diagnosed with malocclusion requiring correction in the mandibular incisors
- Sufficient teeth and bone support to undergo orthodontic treatment
- Good periodontal health or controlled periodontitis
- No orthodontic treatment received in the past six months
- No contraindications to dental surgery or orthodontic treatment
- Able to understand study and provide informed consent
- Available to attend all scheduled treatment and follow-up visits
- Non-smoker or smoke fewer than 10 cigarettes per day
- Radiographic evidence supporting diagnosis and treatment planning
You will not qualify if you...
- Active periodontal disease or significant periodontal bone loss contraindicating orthodontic treatment
- Undergoing concurrent dental procedures that could affect orthodontic outcomes
- Uncontrolled diabetes, bisphosphonate therapy, or history of jaw radiation
- Inability to provide informed consent or comply with study visits
- Smoking more than 10 cigarettes per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a minimally invasive surgical procedure involving piezocision with either a collagen scaffold (Ossix® Volumax) or a deepithelialized free gingival graft. This surgery aims to enhance orthodontic treatment by accelerating tooth movement and supporting bone and soft tissue regeneration.
1 surgical visit (in-person)
Duration - 1 year
Participants receive standardized post-operative care including oral hygiene instructions and medication as needed to support healing and scaffold integration. Follow-up visits assess gingival thickness, alveolar bone volume, and monitor for gingival recession and patient satisfaction.
Visits at 1 month, 6 months, and 1 year post-surgery
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
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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