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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontal Diseases; Intrabony Defects; Guided Tissue Regeneration
• Intervention / Treatment: Device: Guided Tissue Regeneration (GTR)

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Collagen Matrix

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2021
• Primary Completion (ANTICIPATED): July 20, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (ACTUAL): April 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: resorbable collagen membrane
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: D20190472-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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