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

Launched by UNIVERSITY OF FLORENCE · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for improving the soft tissue around dental implants, which are artificial teeth placed in the jawbone. The study compares a special collagen matrix called volume-stable collagen matrix (VCMX) with a traditional procedure using connective tissue graft (CTG). The goal is to find out which method works better for enhancing the appearance and support of the gums around dental implants, which is important for both aesthetics and long-term care.

To be eligible for this trial, participants should be at least 18 years old and generally healthy, without serious medical conditions or recent treatments that could affect their oral health. They should also be scheduled to receive a dental implant and need soft tissue augmentation for cosmetic or functional reasons. Participants can expect to receive one of the two treatments during the implant uncovering process and will be monitored for their recovery and outcomes. It's essential to note that certain conditions, like smoking more than 10 cigarettes a day or having specific health issues, may exclude individuals from participating.

Gender

ALL

Eligibility criteria

• 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