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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: Infrabony defects will be filled with a volume-stable collagen matrix (VCMX); Device: Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra Stähli, MD; Phone Number: +41316840600; Email: alexandra.staehli@unibe.ch
• Study Contact Backup: Name: Andrea Roccuzzo, PhD; Phone Number: +41316840600; Email: andrea.roccuzzo@unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University of Bern
    • Contact: Andrea Roccuzzo, PhD; Email: andrea.roccuzzo@unibe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Infrabony defects will be filled with a volume-stable collagen matrix; Other Names: 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; Infrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen; Other Names: DBBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline, 12 months

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Alexandra Stähli, MD, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: 2024-D0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No