Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants.

Inclusion criteria

• Age: 18 to 80 years.
• Subjects must be able and willing to follow instructions related to the study procedures.
• Subjects must have read, understood and signed an informed consent form.
• At least one single-tooth edentulous site, with adjacent natural teeth, planned for tooth replacement therapy with an implant-supported restoration.

Exclusion criteria

• Reported allergy or hypersensitivity to any of the products to be used in the study.
• Severe hematologic disorders, such as hemophilia or leukemia.
• Active severe infectious diseases that may compromise normal healing.
• Liver or kidney dysfunction/failure.
• Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
• Subjects with uncontrolled diabetes, defined as Hba1c > 6.5% (According to the American Diabetes Association 2014 Guidelines)
• Pregnant women or nursing mothers.
• Smokers: Subjects who have smoked within 6 months of study onset.
• Concomitant medications for systemic conditions that may affect the outcomes of the study.
• Any other non-specified reason that from the point of view of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).