Comparing Two Collagen Bone Substitutes with Minimally Invasive Surgery for Deep Periodontal Defects

What this Trial Is About

Researchers are evaluating two collagenated xenogeneic bone substitutes, GTO4 and GenOs4, combined with a minimally invasive surgery called the Non-Incised Papilla Surgical Approach NIPSA to treat intrabony periodontal defects in patients with Stage III periodontitis. This multicenter randomized controlled trial aims to compare clinical, radiographic, microbiological, and molecular outcomes, including clinical attachment gain, defect healing, and biological markers of bone regeneration. Participants will be randomly assigned to receive regenerative periodontal surgery using either GTO4 or GenOs4 bone substitutes together with the NIPSA technique. The surgery involves a special incision approach designed to preserve soft tissues and improve wound healing. The study will be conducted at two dental schools and will follow patients for 6 months after surgery. Clinical and radiographic assessments will be performed at baseline, immediately after surgery, and at 6 months. During the study, participants will have clinical measures such as probing depth, attachment level, bleeding, and plaque recorded. Microbiological tests and molecular analyses of gene expression related to bone remodeling and vascularization will be done. Early healing and postoperative pain will also be evaluated. The main outcome is clinical attachment level gain at 6 months. The study will help determine differences in regenerative potential between the two bone substitutes when used with this minimally invasive surgical method.

Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial