Periodontal DiseasesNCT06676826
Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen
A study testing 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 people with Periodontal Diseases, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Bern
Bern, 3010
Andrea Roccuzzo, PhD, andrea.roccuzzo@unibe.ch
About this study
Official title: Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen. A 12-month Multi-center Randomized Controlled Trial
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.
- Conditions
- Periodontal Diseases
- Being tested
- Infrabony defects will be filled with a volume-stable collagen matrix (VCMX), Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrabony defects will be filled with a volume-stable collagen matrix (VCMX)Device
Also called VCMX
Infrabony defects will be filled with a volume-stable collagen matrix
Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagenDevice
Also called DBBM
Infrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen
| Study group | Role | What they receive |
|---|---|---|
| Test Group (VCMX) | Experimental | 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. Receives: Device: Infrabony defects will be filled with a volume-stable collagen matrix (VCMX) |
| Control Group (Deproteinized bovine bone mineral) | Active comparator | 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. Receives: Device: Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 1, 3, 12 weeks
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
Measured: Baseline, 12 months
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
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Stähli, MD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676826
- Sponsor's protocol ID
- 2024-D0026
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen. A 12-month Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06676826
- Acronym / sponsor ID
- 2024-D0026
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group (VCMX) | Experimental | Device: Infrabony defects will be filled with a volume-stable collagen matrix (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. |
| Control Group (Deproteinized bovine bone mineral) | Active comparator | Device: Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagenThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrabony defects will be filled with a volume-stable collagen matrix (VCMX)Also: VCMXInfrabony defects will be filled with a volume-stable collagen matrix | Device | Test Group (VCMX) |
| Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagenAlso: DBBMInfrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen | Device | Control Group (Deproteinized bovine bone mineral) |
Primary outcome
Clinical attachment level (CAL) change
Time frame: 12 months
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
3 secondary outcomes
Microbiological analysis
Time frame: 1, 3, 12 weeks
Bleeding on probing (BoP)
Time frame: Baseline, 12 months
Pocket probing depth (PPD)
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Stähli, MD study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Periodontal Diseases, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Stähli, MD (+41316840600, alexandra.staehli@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (CAL) change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.