Clinical trial NCT05458271: Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
Official title: Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge Atrophy
Soft Tissue Augmentation At Dental Implants
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: GT
timeFrame: Immediately After Surgery
measure: GT
timeFrame: 1 week After surgery
measure: GT
timeFrame: 2 weeks After surgery
measure: GT
timeFrame: 4 weeks After surgery
measure: GT
timeFrame: 3 months After surgery
measure: GT
timeFrame: 6 months after surgery
measure: GT
timeFrame: 12 months after surgery
Secondary outcomes:
measure: PROMs
timeFrame: Immediately After Surgery
measure: PROMs
timeFrame: 1 week After surgery
measure: PROMs
timeFrame: 2 weeks After surgery
measure: PROMs
timeFrame: 4 weeks After surgery
measure: PROMs
timeFrame: 3 months After surgery
measure: PROMs
timeFrame: 6 months after surgery
measure: PROMs
timeFrame: 12 months after surgery
measure: KT
timeFrame: At Baseline
measure: KT
timeFrame: 1 week After surgery
measure: KT
timeFrame: 2 weeks After surgery
measure: KT
timeFrame: 4 weeks After surgery
measure: KT
timeFrame: 3 months After surgery
measure: KT
timeFrame: 6 months after surgery
measure: KT
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Università degli Studi di Firenze
state: FI
Study officials:
References: