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

Sponsor
Collagen Matrix (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04851847
Collaborator
(none)
174
Enrollment
1
Location
2
Arms
13.7
Anticipated Duration (Months)
12.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Guided Tissue Regeneration (GTR)
 N/A

Study Design

Study Type:
Interventional
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 :
Jun 10, 2021
Anticipated Primary Completion Date :
Jul 20, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. The change of CAL at 12 weeks after surgery [12 weeks]

    Assessment of clinical attachment level

  2. The change of CAL at 24 weeks after surgery [24 weeks]

    Assessment of clinical attachment level

  3. The change of PD at 12 weeks after surgery [12 weeks]

    Assessment of Probing Depth

  4. The change of PD at 24 weeks after surgery [24 weeks]

    Assessment of Probing Depth

Secondary Outcome Measures

  1. The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery. [12 weeks]

    Effect on Gingival recession

  2. The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery. [24 weeks]

    Effect on Gingival recession

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  4. The baseline PD≥7 mm ;

  5. 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;

  6. The wideness of the keratinized gingiva≥2 mm;

  7. 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

Locations

Site City State Country Postal Code
1 Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine Shanghai China

Sponsors and Collaborators

  • Collagen Matrix

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Collagen Matrix
ClinicalTrials.gov Identifier:
NCT04851847
Other Study ID Numbers:
  • D20190472-P
First Posted:
Apr 21, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Periodontal Diseases

Study Results

No Results Posted as of Mar 9, 2022