Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Connective Tissue Graft; Volume Collagen Matrix Xenograft
• Intervention / Treatment: Device: Geistlich Fibro-Gide®

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manrique Fonseca, DDS; Phone Number: +41316840630; Email: manrique.fonseca@unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University of Bern
    • Contact: Martin Schimmel, Prof.; Phone Number: +41316840630; Email: martin.schimmel@unibe.ch
    • Principal Investigator: Manrique Fonseca, Dr. med. dent.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Informed Consent signed by the subject
• Age ≥ 18 years
• Willingness to sign informed consent and to participate in the study
• Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
• Tooth gap of ≥ 8 mm.
• Presence of natural or artificial opposing dentition
• Sufficient vertical interocclusal space of an implant restoration (7mm)
• Bounded by natural and periodontally stable teeth
• Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

Exclusion Criteria:

• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
• Severe bruxism, clenching habits, or presence of oro-facial pain
• Uncontrolled diabetes mellitus (HbA1c >7.0)
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Severe hematologic disorders
• Any other diseases or medications that may compromise normal wound healing
• Pregnancy or nursing mother
• Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
• Vulnerable subjects
• Known or suspected non-compliance
• Drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A: Connective Tissue Graft (CTG); Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®.
Experimental: Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®; The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.	Device: Geistlich Fibro-Gide®; Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric dimensional changes	To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX	0-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical: PPD	Clinical: Probing depth in neighboring teeth	0-5 years
Clinical BoP	Clinical: Bleeding on probing	0-5 years
Clinical: Suppuration	Clinical: Suppuration on probing	0-5 years
Clinical: Mucosa	Clinical: Apical migration of the marginal mucosa	0-5 years
Clinical: ktw	Clinical: Keratinized tissue width	0-5 years
Clinical: Mobility	Clinical: Mobility	0-5 years
Clinical: Thickness	Clinical: Mucosal thickness	0-5 years
Clinical: Contributing factors	Clinical: Presence of local contributing factors	0-5 years
Patient-reported satisfaction	Questionnaire: Overall patient satisfaction with the treatment provided	0-5 years
Patient-reported esthetics	Questionnaire: Esthetics	0-5 years
Patient-reported discomfort	Questionnaire: Discomfort	0-5 years
Patient-reported pain	Questionnaire: Pain	0-5 years
Prosthetics Survival	Prosthetic-related: Fixed dental prostheses survival rates	0-5 years
Prosthetics Complications	Prosthetic-related: Technical complications	0-5 years
Prosthetics PES-WES	Prosthetic-related: Esthetic score (PES-WES)	0-5 years
Prosthetics: Occlusal	Prosthetic-related: Occlusal contacts (static and dynamic)	0-5 years
Prosthetics: Interproximal	Prosthetic-related: Presence of interproximal contacts.	0-5 years
Radiographics BL	Marginal bone levels	0-5 years
Radiographics PP	Periapical pathosis	0-5 years
Radiographics distance	Distance from the adjacent teeth/implants	0-5 years
Radiographics Contacts	Presence of open contacts	0-5 years
Prosthetics Success	Prosthetic-related: Fixed dental prostheses success rates	0-5 years

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Manrique Fonseca, DDS, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RCT: CTG-VCMX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No