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

NCT06676826 | Recruiting DMC

• 1 other identifier: 2024-D0026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Outcome Measures

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

  12 months

Secondary Outcomes (3)

• Microbiological analysis

  1, 3, 12 weeks

• Bleeding on probing (BoP)

  Baseline, 12 months

• Pocket probing depth (PPD)

  Baseline, 12 months

Study Arms (2)

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.

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.

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

Interventions

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

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

Also known as: VCMX

Test Group (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

Also known as: DBBM

Control Group (Deproteinized bovine bone mineral)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Alexandra Stähli, MD

  University of Bern

  STUDY CHAIR

Central Study Contacts

Alexandra Stähli, MD

CONTACT

+41316840600; alexandra.staehli@unibe.ch

Andrea Roccuzzo, PhD

CONTACT

+41316840600; andrea.roccuzzo@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)