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

University of Bern

Status: Enrolling

Conditions: Volume Collagen Matrix Xenograft; Connective Tissue Graft

Treatments: Device: Geistlich Fibro-Gide®

Study type: Interventional

Funder types: Other

Identifiers

NCT06335628

RCT: CTG-VCMX

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Group A: Connective Tissue Graft (CTG)

No Intervention group

Description:

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 group

Description:

The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.

Treatment:

Device: Geistlich Fibro-Gide®