Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site. (NCT05458271) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
Italy100 participantsStarted 2022-07-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Partic…