A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM

Collagen Matrix

Status: Unknown

Conditions: Guided Tissue Regeneration; Periodontal Diseases; Intrabony Defects

Treatments: Device: Guided Tissue Regeneration (GTR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04851847

D20190472-P

Details and patient eligibility

About

This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.

Enrollment: 174 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 65 years, male or female;

2. patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;

3. Only solitary lesion site requires surgical treatment and must meet the following criteria:

   1. The baseline PD≥7 mm ;
   2. After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected;
   3. The wideness of the keratinized gingiva≥2 mm;
   4. Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;

Exclusion criteria

1. The test tooth has open surgical debridement history within the most recent one years;
2. Known allergy to collagen of animal origin;
3. Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

MatrixflexTM resorbable collagen membrane

Experimental group

Description:

Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects

Treatment:

Device: Guided Tissue Regeneration (GTR)

control group membrane

Active Comparator group

Description:

Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects

Treatment:

Device: Guided Tissue Regeneration (GTR)