Actively Recruiting
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
Led by University of Bern · Updated on 2026-05-27
38
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research compares two surgical methods aimed at improving soft tissue volume in areas where teeth are missing. Both techniques, connective tissue graft and volume collagen matrix xenograft, have been validated before, but limited data exist about their differences. The goal is to assess volumetric changes and gather clinical measurements alongside patient satisfaction over time. Participants will be randomly assigned to one of two groups: Group A receives the connective tissue graft, considered the gold standard and control, while Group B receives the experimental collagen matrix xenograft called Geistlich Fibro-Gide4. Soft tissue changes will be monitored using intraoral scans before and after surgery, including follow-ups up to 5 years post-operation. During the study, participants will undergo assessments such as clinical evaluations of tissue health, patient-reported satisfaction and discomfort, and prosthetic outcomes. Researchers will use advanced software to measure volume changes and track various clinical and radiographic parameters over 5 years. The study includes regular follow-ups and safety monitoring throughout this period.
CONDITIONS
Brief Title
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Willingness to participate and sign informed consent
- Single tooth gap or extended edentulous space in the lower or posterior jaw with soft tissue deficiency
- Tooth gap of at least 8 mm
- Presence of natural or artificial opposing dentition
- Sufficient vertical interocclusal space of 7 mm for implant restoration
- Area bounded by natural and periodontally stable teeth
- Treatment plan includes tooth replacement with implant or tooth-supported fixed dental prosthesis
You will not qualify if you...
- Physical or mental disorders interfering with oral hygiene or consent
- Severe bruxism, clenching, or oro-facial pain
- Uncontrolled diabetes mellitus (HbA1c >7.0)
- Significant concomitant diseases (renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Active oral or systemic acute infections
- Current or past chemo- or radiotherapy in head and neck area
- Severe hematologic disorders
- Diseases or medications compromising wound healing
- Pregnancy or nursing
- Contraindications for the medical device such as porcine sensitivity or collagen allergies
- Vulnerable subjects
- Known or suspected non-compliance
- Drug or alcohol abuse
- Inability to follow study procedures due to language or psychological issues
- Participation in another investigational drug or device study within 30 days
- Enrollment of principal investigator, family, employees, or dependents
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate post-operative care
Participants undergo surgical pontic site development procedures using either a connective tissue graft or a volume collagen matrix xenograft device for soft tissue augmentation in the oral and maxillofacial area.
1 surgery visit and several immediate post-operative visits
Duration - Up to 5 years
Participants are monitored for volumetric dimensional changes and clinical outcomes related to soft tissue augmentation, prosthetics, and patient-reported outcomes up to 5 years after surgery.
Multiple follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
University of Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
M
Manrique Fonseca, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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