A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
Primary Purpose
Periodontal Diseases, Intrabony Defects, Guided Tissue Regeneration
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Guided Tissue Regeneration (GTR)
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring resorbable collagen membrane
Eligibility Criteria
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;
Sites / Locations
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MatrixflexTM resorbable collagen membrane
control group membrane
Arm Description
Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects
Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects
Outcomes
Primary Outcome Measures
The change of CAL at 12 weeks after surgery
Assessment of clinical attachment level
The change of CAL at 24 weeks after surgery
Assessment of clinical attachment level
The change of PD at 12 weeks after surgery
Assessment of Probing Depth
The change of PD at 24 weeks after surgery
Assessment of Probing Depth
Secondary Outcome Measures
The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.
Effect on Gingival recession
The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.
Effect on Gingival recession
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04851847
Brief Title
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
Official Title
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collagen Matrix
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Intrabony Defects, Guided Tissue Regeneration
Keywords
resorbable collagen membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MatrixflexTM resorbable collagen membrane
Arm Type
Experimental
Arm Description
Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects
Arm Title
control group membrane
Arm Type
Active Comparator
Arm Description
Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects
Intervention Type
Device
Intervention Name(s)
Guided Tissue Regeneration (GTR)
Intervention Description
Use of resorbable collagen membrane to treat periodontal intrabony defects.
Primary Outcome Measure Information:
Title
The change of CAL at 12 weeks after surgery
Description
Assessment of clinical attachment level
Time Frame
12 weeks
Title
The change of CAL at 24 weeks after surgery
Description
Assessment of clinical attachment level
Time Frame
24 weeks
Title
The change of PD at 12 weeks after surgery
Description
Assessment of Probing Depth
Time Frame
12 weeks
Title
The change of PD at 24 weeks after surgery
Description
Assessment of Probing Depth
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.
Description
Effect on Gingival recession
Time Frame
12 weeks
Title
The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.
Description
Effect on Gingival recession
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
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