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RecruitingNCT06676826Updated Oct 6, 2025

Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen

An interventional study of Infrabony defects will be filled with a volume-stable collagen matrix (VCMX) and Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen in Periodontal Diseases, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the healing of intrabony periodontal defects treated with either open flap debridement and a volume-stable collagen matrix (VCMX) or a deproteinized bovine bone mineral with 10% collagen. The results will shed light on the clinical potential of VCMX in regenerative periodontal surgery and help to develop new treatment strategies.

02

Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's planned enrollment of 80 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria

  • Patients with localized or generalized periodontitis Stage III and Stage IV, Grade A-B-C
  • Males and females
  • Age at least 18 years and older
  • Presence of interdental intra-bony defects (I, II and III walls) in either the maxilla or the mandible with a PD ≥ 6 mm
  • Defects with an intra-bony component \> 3 mm for both groups
  • Intra-bony defect located only at one aspect (mesial or distal)
  • Presence of at least 2 mm of keratinized soft tissue. Exclusion Criteria
  • Patients with systemic disease that could interfere with periodontal wound healing
  • Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
  • Pregnant or lactating
  • Smokers with \> 10 cig./day
  • Patients with FMPS and FMBS \> 25 % after completion of non-surgical periodontal therapy
  • Multi-rooted teeth with furcation involvement
  • Third molars
  • Teeth with circumferential defects
  • Interdental craters
  • Written Informed Consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Test Group (VCMX)

    The periodontal infrabony defect will be opened by a papilla preservation flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with a volume-stable collagen matrix (VCMX) only.

    Device: Infrabony defects will be filled with a volume-stable collagen matrix (VCMX)

  • Active comparator
    Control Group (Deproteinized bovine bone mineral)

    The periodontal infrabony defect will be opened by a flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with deproteinized bovine bone mineral with 10% collagen.

    Device: Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen

Interventions

  • DeviceInfrabony defects will be filled with a volume-stable collagen matrix (VCMX)

    Infrabony defects will be filled with a volume-stable collagen matrix

    Also known as: VCMX

  • DeviceInfrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen

    Infrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen

    Also known as: DBBM

06

What researchers measure

Primary outcomes

  1. Clinical attachment level (CAL) change

    Clinical attachment level (CAL) change in mm: the distance from the cemento-enamel junction to the bottom of the clinical periodontal pocket is being measured

    Time frame: 12 months

Secondary outcomes

  1. Microbiological analysis

    Quantification of the concentration of host-derived biomarkers (interleukin-1beta (IL-1b), IL-10, matrix-metalloproteinase- 8(MMP-8)) and periodontal bacterial species by means of gingival crevicular fluid and the biofilm sampling

    Time frame: 1, 3, 12 weeks

  2. Bleeding on probing (BoP)

    Assessment of number of bleeding spots (percentage 0-100%) upon gentle probing of PPD at each test and control tooth site

    Time frame: Baseline, 12 months

  3. Pocket probing depth (PPD)

    With a periodontal probe with mm markings, the distance between the gingival margin and the bottom of the pocket will be measured

    Time frame: Baseline, 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06676826
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Nov 6, 2024
Start date
Sep 1, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 6, 2025

Study contacts

Alexandra Stähli, MD
Contact
alexandra.staehli@unibe.ch
+41316840600
Andrea Roccuzzo, PhD
Contact
andrea.roccuzzo@unibe.ch
+41316840600
Alexandra Stähli, MD
study chair · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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