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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851847
Recruitment Status : Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Collagen Matrix

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Intrabony Defects Guided Tissue Regeneration Device: Guided Tissue Regeneration (GTR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : July 20, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: MatrixflexTM resorbable collagen membrane
Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects
 Device: Guided Tissue Regeneration (GTR)
Use of resorbable collagen membrane to treat periodontal intrabony defects.
Active Comparator: control group membrane
Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects
 Device: Guided Tissue Regeneration (GTR)
Use of resorbable collagen membrane to treat periodontal intrabony defects.


Outcome Measures
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Primary Outcome Measures :
  1. The change of CAL at 12 weeks after surgery [ Time Frame: 12 weeks ]
    Assessment of clinical attachment level

  2. The change of CAL at 24 weeks after surgery [ Time Frame: 24 weeks ]
    Assessment of clinical attachment level

  3. The change of PD at 12 weeks after surgery [ Time Frame: 12 weeks ]
    Assessment of Probing Depth

  4. The change of PD at 24 weeks after surgery [ Time Frame: 24 weeks ]
    Assessment of Probing Depth


Secondary Outcome Measures :
  1. The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery. [ Time Frame: 12 weeks ]
    Effect on Gingival recession

  2. The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery. [ Time Frame: 24 weeks ]
    Effect on Gingival recession


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851847


Locations
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China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Collagen Matrix
More Information
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Responsible Party: Collagen Matrix
ClinicalTrials.gov Identifier: NCT04851847    
Other Study ID Numbers: D20190472-P
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Collagen Matrix:
resorbable collagen membrane
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases