NCT07324187

CTG vs VCMX for Peri-implant Soft Tissue Thickness

Peri-implant Soft Tissue Thickness in the Aesthetic Zone: A Randomized Controlled Clinical Trial Comparing Connective Tissue Grafts and a Volume-Stable Collagen Matrix

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Medical Innovation Center Wroclaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigator-initiated randomized controlled clinical trial evaluated changes in peri-implant soft tissue thickness in the aesthetic zone following soft tissue augmentation. Adult patients requiring single-tooth implant therapy in the aesthetic zone were randomly assigned to receive either an autogenous connective tissue graft (CTG) or a volume-stable collagen matrix (VCMX) at the implant site. The primary objective of the study was to compare changes in peri-implant soft tissue thickness between the two treatment approaches over time. Secondary objectives included evaluation of aesthetic outcomes, clinical parameters, and treatment-related complications. The study was conducted at a single academic clinical center in Poland in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. All participants provided written informed consent prior to enrollment.

Detailed description

This investigator-initiated, single-center, randomized controlled clinical trial was designed to assess the effectiveness of two different soft tissue augmentation approaches on peri-implant soft tissue thickness in the aesthetic zone. The study compared the use of an autogenous connective tissue graft (CTG) with a volume-stable collagen matrix (VCMX) in patients undergoing single-tooth implant therapy. Eligible adult patients presenting with an indication for peri-implant soft tissue augmentation in the aesthetic zone were enrolled and randomly allocated in a 1:1 ratio to one of the two intervention groups. In the CTG group, a subepithelial connective tissue graft was harvested from the palate and placed at the peri-implant site. In the VCMX group, a commercially available volume-stable collagen matrix was used for soft tissue augmentation according to the manufacturer's instructions. Standardized surgical and prosthetic protocols were applied in both groups. Clinical examinations and outcome assessments were performed at predefined follow-up visits. The primary outcome measure was the change in peri-implant soft tissue thickness measured at the implant site over time. Secondary outcome measures included additional clinical parameters, aesthetic outcomes, patient-reported outcomes, and the incidence of adverse events or complications. The study protocol, patient information sheet, and informed consent form were approved by the Bioethics Committee of Wroclaw Medical University prior to study initiation. The study was conducted in compliance with Good Clinical Practice guidelines, ISO 14155, and the principles of the Declaration of Helsinki. All participants provided written informed consent before any study-related procedures were performed.

Conditions

• Dental Implants
• Peri-Implant Tissues
• Missing Tooth/Teeth

Interventions

Type	Name	Description
PROCEDURE	Connective Tissue Graft	An autogenous subepithelial connective tissue graft harvested from the palatal donor site and used for peri-implant soft tissue augmentation according to a standardized surgical protocol.
DEVICE	Volume-Stable Collagen Matrix	A volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol.

Timeline

• Start date: 2022-01-02
• Primary completion: 2025-04-10
• Completion: 2025-04-19
• First posted: 2026-01-07
• Last updated: 2026-01-16

Locations

1 site across 1 country: Poland