Loading clinical trials...

Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.

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

NCT05458271•University of Florence

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Università degli Studi di Firenze

Florence, FI, Italy

Key Dates

Start Date

July 31, 2022

Primary Completion Date

October 31, 2023

Completion Date

June 25, 2025

Last Updated

December 6, 2024

Enrollment

100

ACTUAL participants

Conditions

Edentulous Alveolar Ridge AtrophySoft Tissue Augmentation At Dental Implants

Interventions

VCMX

DEVICE

CTG

PROCEDURE

Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study

NCT07014527

Edentulous Alveolar Ridge AtrophyATROPHYC EDENTULOUS JAW+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions