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NCT Number: NCT06676826

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

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.

Recruiting

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Andrea Roccuzzo, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Other names: VCMX

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

Device

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

Other names: DBBM

Primary outcomes

  1. 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

Secondary outcomes

  1. Microbiological analysis

    Time frame: 1, 3, 12 weeks

    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

  2. Bleeding on probing (BoP)

    Time frame: Baseline, 12 months

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

  3. Pocket probing depth (PPD)

    Time frame: Baseline, 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Stähli, MD

CONTACT

[email protected]

+41316840600

Andrea Roccuzzo, PhD

CONTACT

[email protected]

+41316840600

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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