Comparing Three Graft Materials to Increase Soft Tissue Thickness Around Dental Implants A Randomized Clinical Trial Measuring Volume Gain and Stability

What this Trial Is About

Researchers are comparing changes in soft tissue volume and patient-reported outcomes around dental implants using three different graft materials a sub-epithelial connective tissue graft SCTG from the palate, porcine collagen matrix CM, and porcine acellular dermal matrix PADM. This phase 4 randomized clinical trial aims to evaluate volume gain and stability at 3 and 15 months after implant placement. The study involves four groups one receiving implant placement and prosthetic tooth rehabilitation alone, and three groups receiving implant placement plus soft tissue augmentation with either SCTG, CM, or PADM at the implant site, followed by prosthetic rehabilitation. SCTG grafts are harvested from the palate and trimmed to specific dimensions, while CM and PADM grafts are similarly trimmed and secured at the recipient site. Implant placement includes making a crestal incision and preparing the bone to place a tapered implant with a healing abutment. Participants will undergo assessments including soft tissue volume gain at 3 months and volume stability at 15 months. Additional measures include plaque index, bleeding on probing, probing depth, keratinized tissue width, phenotype evaluation at baseline, 12 weeks, and 15 months, as well as patient-reported outcomes shortly after surgery. Pink Esthetic Score will be evaluated around 16 months after crown placement. Safety and progress will be monitored throughout the study with a total participation period extending beyond 15 months.

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.