CTG vs VCMX for Peri-implant Soft Tissue Thickness

NCT07324187 | Completed

• 1 other identifier: 400166
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

connective tissue graft,; collagen matrix; peri-implant soft tissue; CTG; VCMX

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant soft tissue thickness

  Change in peri-implant soft tissue thickness measured at the implant site using a standardized clinical measurement method.

  Baseline and 6 months after soft tissue augmentation

Secondary Outcomes (1)

• Peri-implant soft tissue thickness at additional follow-up time points

  Baseline, 3 months, and 12 months after augmentation

Study Arms (2)

Connective Tissue Graft (CTG)

ACTIVE COMPARATOR

Participants received peri-implant soft tissue augmentation using an autogenous subepithelial connective tissue graft harvested from the palate and placed at the implant site according to a standardized surgical protocol.

Procedure: Connective Tissue Graft

Volume-Stable Collagen Matrix (VCMX)

EXPERIMENTAL

Participants received peri-implant soft tissue augmentation using a volume-stable collagen matrix placed at the implant site according to the manufacturer's instructions and a standardized surgical protocol.

Device: Volume-Stable Collagen Matrix

Interventions

Volume-Stable Collagen Matrix DEVICE

A volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol.

Volume-Stable Collagen Matrix (VCMX)

Connective Tissue Graft PROCEDURE

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.

Connective Tissue Graft (CTG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Single-tooth edentulism in the aesthetic zone of the maxilla or mandible, bordered by natural teeth on both sides.
• Bilateral two-tooth edentulism accepted only when implants were placed in separate quadrants.
• Indication for dental implant placement with peri-implant soft tissue augmentation.
• Adequate bone volume at the implant site confirmed radiographically.
• Baseline peri-implant soft tissue thickness suitable for augmentation.
• Minimum height of keratinized tissue of at least 2 mm.
• Good oral hygiene and periodontal health.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Previous bone grafting procedures at the intended implant site.
• Severe periodontal disease or untreated oral infection.
• Bruxism or heavy smoking.
• Systemic diseases or conditions that could impair wound healing or bone metabolism.
• History of radiotherapy in the head and neck region.
• Previous or ongoing bisphosphonate therapy.
• Uncontrolled diabetes mellitus.
• Pregnancy or breastfeeding.
• Use of medications known to interfere with soft tissue healing.

Sponsors & Collaborators

• Geistlich Pharma AG: collaborator
• Medical Innovation Center Wroclaw: lead

Study Sites (1)

Medyczne Centrum Innowacji Wrocław (Wrocław Medical Innovation Center), formerly operating as Akademicka Akademicka Poliklinika Stomatologiczna

Wroclaw, Poland

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessments were performed by an independent examiner who not involved in the surgical procedures unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, DSc (Med.), Specialist in Oral Surgery

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 2, 2022
• Primary Completion: April 10, 2025
• Study Completion: April 19, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)