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05 / Clinical Studies

Clinical
studies.

Generating histopathological evidence from clinical biopsies and explants for efficacy evaluation, clinical surveillance and post-market clinical follow-up.

Tissue response, implant integration and degradation in clinical specimens.

The study scope

Evidence from
clinical specimens.

Connecting biopsy and explant findings with the clinical question and the tissue endpoints of the commissioned investigation.

Biopsies and explants

Investigating available clinical tissue, explants and retrieved devices with preparation and evaluation matched to the specimen.

Histopathological evidence from the tissue available for assessment.

Surveillance and follow-up

Assessing the specified tissue features in support of efficacy evaluation, clinical surveillance or post-market clinical follow-up.

Findings interpreted within the clinical and specimen context.

The service covers specimen processing and histopathological analysis within the clinical study or follow-up programme.

Published clinical evidence

Evidence of function.
From clinical studies.

Quantifying tissue regeneration, augmentation and integration, and connecting those findings with clinical outcomes.

Selected human studies co-authored by Prof. Dr. Mike Barbeck.

01 / Bone regeneration · Randomized clinical study

Regenerated tissue.
Ready for implant placement.

40 patients · 6 months · 29 evaluable biopsies

Comparing two sinus-augmentation approaches using the same xenogenic bone substitute: bony-wall repositioning and collagen-membrane coverage.

Published graph of tissue distribution at six months. Bony-wall versus collagen-membrane groups: new bone 27.8 versus 30.3 percent; remaining substitute 32.9 versus 31.8 percent; connective tissue 39.2 versus 37.9 percent. Error bars show standard deviations.
Figure 6 reproduced unchanged from Molnár et al. (2022). © The authors, CC BY 4.0. Solid bars: bony wall / piezosurgery; hatched bars: collagen membrane. CT: connective tissue. The original significance marker concerns tissue fractions, not superiority of one surgical approach.
Measured
New bone, residual substitute and connective-tissue fractions. No significant between-group differences were reported.
Clinical outcome
All 40 sites supported implant placement at six months without additional grafting.
Actionable evidence
Combining tissue composition with clinical assessment to evaluate whether regeneration supports the next treatment stage.
Study measurements and context
Tissue fraction at six months · Mean ± SD (%)
TissueBony wall
13 biopsies
Membrane
16 biopsies
New bone27.8 ± 11.230.3 ± 4.5
Remaining substitute32.9 ± 6.331.8 ± 8.8
Connective tissue39.2 ± 9.037.9 ± 8.5

Forty patients were randomized, 20 per group. Twenty-nine biopsies were evaluable; eleven were excluded because of insufficient measurable material or processing difficulties. Histomorphometry was a secondary endpoint. The study compared surgical approaches, not different bone substitutes. Mike Barbeck is credited with histomorphometric analysis. These findings do not establish long-term implant equivalence.

Read the clinical study

02 / Soft-tissue augmentation · Clinical case series

Tissue gain,
measured in patients.

20 patients · 2 months · Collagen matrix augmentation

Clinical thickness measurements paired with biopsy analysis of graft integration.

Mean soft-tissue thickness in 20 patients increased from 1.65 plus or minus 0.36 millimetres before augmentation to 3.45 plus or minus 0.52 millimetres at two months. Error bars show standard deviations.
Original chart plotted from published summary data in Puisys et al. (2019). Bars: mean; error bars: standard deviation. This is a before-and-after case series, without a control group.
Measured
Mean thickness increased from 1.65 mm to 3.45 mm at two months (P < .001).
Histological finding
Biopsies showed integration of the collagen matrix into the surrounding tissue.
Actionable evidence
Quantifying the achieved augmentation and assessing graft integration against the material’s intended clinical function.

Short-term tissue gain and integration were evaluated; improved implant survival was not established by this case series.

Study measurements and context
Soft-tissue thickness · Mean ± SD
AssessmentThickness (mm)
Before augmentation1.65 ± 0.36
At two months3.45 ± 0.52

Twenty patients received a porcine-derived collagen matrix during implant treatment. Clinical measurements and biopsies were evaluated at two months. The plotted values are reported group means and standard deviations; individual patient data are not reconstructed.

Read the clinical study

Further reading

Selected clinical publications.

Co-authored by Prof. Dr. Mike Barbeck. Titles below summarise each paper; links open the published articles.

  1. 2022
    Lateral sinus augmentation: bony wall versus collagen membrane

    Molnár et al. · Clinical Oral Investigations · Randomized clinical and histological study; 40 patients, six months.

  2. 2019
    Vertical soft-tissue augmentation with a porcine collagen matrix

    Puisys et al. · International Journal of Periodontics & Restorative Dentistry · Clinical and histological case series; 20 patients, two months.

  3. 2017
    Expanding peri-implant attached gingiva in head and neck cancer patients

    Lorenz et al. · Clinical Oral Investigations · Prospective clinical and histological study; eight patients, six months.

  4. 2016
    Volume maintenance of bone substitutes in the human sinus

    Lorenz et al. · Annals of Maxillofacial Surgery · Randomized split-mouth clinical study; eight patients, six months.

Explore recent clinical studies · 2026

Optional technical detail

How the evidence
is produced.

Retaining the structures that matter in the available specimen and connecting the analytical findings with the clinical question.

Explore processing & analysis
Specimen-specific preparation

Selecting undecalcified processing when mineralised structures or implant interfaces require preservation, and appropriate soft-tissue processing for biopsies and other tissue specimens. Preparation is planned around the specimen received and the study endpoints.

Staining and histopathology

Selecting stains and, where relevant, immunohistochemistry for the tissue and cellular features under investigation. Interpreting the section findings in the context of the submitted clinical information.

Study-defined analysis

Applying the qualitative and quantitative evaluations appropriate to the commissioned endpoints and available tissue. Reporting observations with the specimen and methodological context needed for their interpretation.

Your next investigation

What can your
specimens establish?

Connect the clinical question with the tissue available and the analysis needed for your study or follow-up programme.

Discuss clinical specimens

A useful starting point

  • Specimen type, tissue site and device or biomaterial
  • Clinical question and available specimen context
  • Endpoints and intended use of the histopathological evidence