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 enrollmentStarted: July 31, 2022Last updated: December 6, 2024

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: University of Florence
Enrollment: 100
Locations: 1
Primary Endpoint: GT

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Investigator, Outcomes Assessor)

Masking Description

Examiners will be blinded throughout all experimental procedures for all measurements.

Operators will be blinded until they will raise the flap and screw the healing abutment.

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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
•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

Arms & Interventions

VCMX

Experimental

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.

Intervention: VCMX (Device)

CTG

Active Comparator

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.

Intervention: CTG (Procedure)