About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
Procedure/SurgeryA 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.
control
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
Increase in Gingival Thickness and Alveolar Bone Volume
The primary endpoint is the quantifiable increase in gingival thickness and alveolar bone volume at the sites of orthodontic intervention. Gingival thickness will be defined as the distance from the gingival margin to the alveolar bone crest, and bone volume will be measured in cubic millimeters.
Secondary outcomes
Risk Reduction of Gingival Recession
A decrease in the incidence of gingival recession post-treatment, characterized by the exposure of the roots of the teeth as measured from the cementoenamel junction (CEJ) to the gingival margin.
Decrease in Duration of Surgery
This refers to the actual time taken to complete the surgical aspect of the treatment, from the initial incision to the final suture or equivalent closing procedure.
Orthodontic Treatment Time
The time required from the initiation of orthodontic appliance placement to the achievement of the desired dental alignment and occlusion
Patient Satisfaction and Quality of Life
This endpoint assesses the patient's subjective satisfaction with the treatment outcomes and the impact on their quality of life. Measurement Tools: Validated questionnaires such as the Oral Health Impact Profile (OHIP) and patient satisfaction surveys will be utilized.
Sponsors and contacts
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