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

Launched by UNIVERSITY OF BERN · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods aimed at improving the volume of soft tissue in the mouth, specifically after losing a tooth. Both methods, one using a connective tissue graft and the other using a collagen matrix, have been used before, but there is not much detailed information about how they compare. The researchers want to find out which method is more effective at increasing tissue volume and also gauge how satisfied patients are with the results.

To participate in this trial, you need to be at least 18 years old and have a gap where a tooth is missing, ideally measuring 8 mm or more. You should also have stable teeth surrounding the gap, and your treatment plan should include replacing the missing tooth with an implant or a fixed dental prosthesis. Participants will undergo the surgical procedure, followed by assessments to track changes and gather feedback about their experiences. If you have certain health conditions or are currently pregnant or breastfeeding, you may not be eligible for this study.

Gender

ALL

Eligibility criteria

• 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