Comparing two surgical methods for improving soft tissue volume in dental procedures
Official title: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
Run by University of Bern · NCT06335628 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | August 28, 2024 |
| Main results expected | April 2027 |
| Study ends | April 2030 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06335628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe bruxism, uncontrolled diabetes, or significant concomitant diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While both procedures have been validated, there is limited literature data, indicating that this study may provide novel insights into their comparative effectiveness.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Grafting Techniques for Thin Gingival Tissues with Delayed Implants
This study tests whether sub-epithelized versus de-epithelized connective tissue grafts improve outcomes for delayed dental implants in people with thin gums.
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Multilayered PRF versus connective tissue graft for anterior implant tissue health
This study tests whether multilayered platelet-rich fibrin can improve soft tissue around front-mouth dental implants as well as the traditional connective tissue graft.
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Gum tissue build-up at a missing-tooth pontic site with or without a fixed partial denture
We will test whether connective tissue grafts can improve gum thickness and contour at a single missing-tooth site in adults, comparing sites that have an existing fixed partial denture to sites without one.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.