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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects

Conditions
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Periodontal Diseases, Intrabony Defects, Guided Tissue Regeneration

Intervention / Treatment
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* Device: Guided Tissue Regeneration (GTR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 years, male or female; patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999; Only solitary lesion site requires surgical treatment and must meet the following criteria: The baseline PD≥7 mm ; 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; The wideness of the keratinized gingiva≥2 mm; Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm; Exclusion Criteria: The test tooth has open surgical debridement history within the most recent one years; Known allergy to collagen of animal origin; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MatrixflexTM resorbable collagen membrane<br>Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects | Device: Guided Tissue Regeneration (GTR)<br>* Use of resorbable collagen membrane to treat periodontal intrabony defects.<br>|
| Active Comparator: control group membrane<br>Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects | Device: Guided Tissue Regeneration (GTR)<br>* Use of resorbable collagen membrane to treat periodontal intrabony defects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of CAL at 12 weeks after surgery | Assessment of clinical attachment level | 12 weeks | 
| The change of CAL at 24 weeks after surgery | Assessment of clinical attachment level | 24 weeks | 
| The change of PD at 12 weeks after surgery | Assessment of Probing Depth | 12 weeks | 
| The change of PD at 24 weeks after surgery | Assessment of Probing Depth | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery. | Effect on Gingival recession | 12 weeks | 
| The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery. | Effect on Gingival recession | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resorbable collagen membrane