Study of Collagen Scaffold Ossix VOLUMAX and Piezo-Surgical Decortication to Improve Orthodontic Treatment in Adults with Thin Gum Tissue and Malocclusion

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.

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