Safety and Effectiveness of NovoMatrix for Treating Gingival Recession in Adults Aged 20 to 70

What this Trial Is About

Researchers are studying the safety and effectiveness of NovoMatrix for treating gingival recession, which affects the gums around teeth. The trial will involve patients aged 20 to 70 who have multiple adjacent sites of gum recession classified as Miller Class I or II, with at least 3 teeth affected. This pilot clinical and histological case series aims to evaluate how well NovoMatrix works for gingival augmentation using accepted dental surgery protocols and follow-up assessments. The treatment involves a surgical procedure called a coronally advanced tunnel where NovoMatrix, a graft material, is placed under the gum tissue to cover exposed roots. The surgery includes local anesthesia, creating a tunnel under the gums, inserting the graft, and securing it with sutures. Follow-up care includes cleaning, oral hygiene instructions, and monitoring at multiple time points up to 6 months post-surgery. Additionally, 5 patients who require tooth extraction for orthodontic or restorative reasons will undergo a block biopsy at 6 months to analyze tissue histology. Participants will attend visits for evaluations before surgery and at days 0, 1, 4, 7, 10, 14, and months 1, 3, and 6 afterwards. Various measurements will be taken such as plaque and gingival indexes, probing depths, recession dimensions, and tissue thickness using probes and imaging devices. Blood flow in the gums will also be monitored using laser imaging. Any adverse events will be recorded. The study duration from treatment to biopsy is up to 6 months, with implant placement or other dental restorations planned around 9 months after biopsy.

NovoMatrix in Gingival Recession Coverage: Case Series