Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.

Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial

Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.

The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.

Inclusion Criteria:

• Age ≥18 years.
• No systemic diseases or pregnancy.
• Self-reported smoking ≤10 cigarettes/day.
• No probing depths ≥5 mm
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
• Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering.
• Need of soft tissue augmentation for aesthetic purpose and/or functional reasons
• No previous soft tissue augmentation procedure at experimental site.

Exclusion Criteria:

• General contraindications for dental and/or surgical treatments
• Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
• Inflammatory and autoimmune disease of oral cavity
• History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
• Radiotherapy of head area
• Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
• Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
• Untreated acute periodontal disease
• Patients who smoke more than 10 cigarettes/day will be excluded from the study
• Diabetes
• Allergy to the collagen
• Pregnant or lactating women
• Women of child bearing age, not using a highly effective method of birth control
• Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start