Comparing two surgical methods for improving soft tissue volume in dental procedures
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
NA · University of Bern · NCT06335628
This study is testing which of two surgical methods, a connective tissue graft or a collagen matrix, works better to improve soft tissue volume around dental implants for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06335628 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two surgical procedures—connective tissue graft and collagen matrix—in enhancing soft tissue volume around dental implants. Both methods have been previously validated, but there is limited data on their volumetric outcomes. The study will evaluate changes in tissue volume and gather clinical measurements, along with assessing patient satisfaction. Participants will undergo one of the two procedures to determine which is more effective in achieving the desired results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a single tooth gap or extended edentulous space in the lower or posterior jaw and a soft tissue deficiency.
Not a fit: Patients with severe bruxism, uncontrolled diabetes, or significant concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for enhancing soft tissue volume, benefiting patients undergoing dental implant procedures.
How similar studies have performed: While both procedures have been validated, there is limited literature data, indicating that this study may provide novel insights into their comparative effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- University of Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Manrique Fonseca, DDS — University of Bern
- Study coordinator: Manrique Fonseca, DDS
- Email: manrique.fonseca@unibe.ch
- Phone: +41316840630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Connective Tissue Graft, Volume Collagen Matrix Xenograft