Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
NCT ID: NCT05458271
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-07-31
2025-06-25
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Operators will be blinded until they will raise the flap and screw the healing abutment.
Study Groups
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VCMX
All patients will be treated by scaling/root planing to obtain infection control if needed. In addition, patients will receive oral hygiene instructions.
The test group will be treated with add of VCMX. Following the local anesthesia, a split thickness flap will be raised-up to uncover the implant screw. Care will be taken to preserve pre-existing KT amount. A mesio-distal and apical partial thickness dissection will be performed to release residual muscle tension and allow the passive apical displacement of the flap. The randomisation envelope will be then opened. In test group the VCMX will be gently shaped and secured under the flap with suture. Care will be applied to completely cover the xenograft.
VCMX
A flap will be raised and VCMX will be placed in order to increase the soft tissue volume
CTG
The control group patients will be treated by flap surgery with add of CTG. In the control group (APF) a CTG harvested from palate will be secured under the flap with suture.
CTG
A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume
Interventions
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VCMX
A flap will be raised and VCMX will be placed in order to increase the soft tissue volume
CTG
A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Dr. Francesco Cairo
Prof.
Locations
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Università degli Studi di Firenze
Florence, FI, Italy
Countries
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Other Identifiers
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VCMX vs CTG
Identifier Type: -
Identifier Source: org_study_id