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

University of Bern

Status: Enrolling

Conditions: Periodontal Diseases

Treatments: 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

Funder types: Other

Identifiers

NCT06676826

2024-D0026

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Test Group (VCMX)

Experimental group

Description:

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.

Treatment:

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

Control Group (Deproteinized bovine bone mineral)

Active Comparator group

Description:

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.

Treatment:

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