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

NCT06335628 | Recruiting

• 1 other identifier: RCT: CTG-VCMX
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Volume Collagen Matrix Xenograft; Connective Tissue Graft

Outcome Measures

Primary Outcomes (1)

• Volumetric dimensional changes

  To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX

  0-5 years

Secondary Outcomes (22)

• Clinical: PPD

  0-5 years

• Clinical BoP

  0-5 years

• Clinical: Suppuration

  0-5 years

• Clinical: Mucosa

  0-5 years

• Clinical: ktw

  0-5 years

Study Arms (2)

Group A: Connective Tissue Graft (CTG)

NO INTERVENTION

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®.

Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®

EXPERIMENTAL

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®

Interventions

Geistlich Fibro-Gide® DEVICE

Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.

Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Manrique Fonseca, DDS

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manrique Fonseca, DDS

CONTACT

+41316840630; manrique.fonseca@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: August 28, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)