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

University of Florence1 site in 1 country100 target enrollmentJuly 31, 2022

ConditionsEdentulous Alveolar Ridge Atrophy Soft Tissue Augmentation At Dental Implants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Edentulous Alveolar Ridge Atrophy
Sponsor: University of Florence
Enrollment: 100
Locations: 1
Primary Endpoint: GT
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 31, 2022

End Date

June 25, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Florence

Responsible Party

Principal Investigator

Dr. Francesco Cairo

Prof.

University of Florence

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
•Allergy to the collagen

Outcomes

Primary Outcomes

Time Frame: 12 months after surgery

Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.