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

NCT ID: NCT06676826

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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VCMX DBBM

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Stähli, MD

Role: STUDY_CHAIR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Alexandra Stähli, MD

Role: CONTACT

+41316840600

Andrea Roccuzzo, PhD

Role: CONTACT

+41316840600

Facility Contacts

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Andrea Roccuzzo, PhD

Role: primary

Other Identifiers

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2024-D0026

Identifier Type: -

Identifier Source: org_study_id

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