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Status unknownNCT04851847Updated Mar 9, 2022

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

An interventional study of Guided Tissue Regeneration (GTR) in Periodontal Diseases, Intrabony Defects and Guided Tissue Regeneration, sponsored by Collagen Matrix. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Collagen Matrix · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases
  • Intrabony Defects
  • Guided Tissue Regeneration

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Keywords

  • resorbable collagen membrane
03

In context

Periodontal Diseases

855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's enrollment of 174 is above the median of 45 across 546 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Collagen Matrix is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
174 participants (actual)

Study arms

  • Experimental
    MatrixflexTM resorbable collagen membrane

    Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects

    Device: Guided Tissue Regeneration (GTR)

  • 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)

Interventions

  • DeviceGuided Tissue Regeneration (GTR)

    Use of resorbable collagen membrane to treat periodontal intrabony defects.

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What researchers measure

Primary outcomes

  1. The change of CAL at 12 weeks after surgery

    Assessment of clinical attachment level

    Time frame: 12 weeks

  2. The change of CAL at 24 weeks after surgery

    Assessment of clinical attachment level

    Time frame: 24 weeks

  3. The change of PD at 12 weeks after surgery

    Assessment of Probing Depth

    Time frame: 12 weeks

  4. The change of PD at 24 weeks after surgery

    Assessment of Probing Depth

    Time frame: 24 weeks

Secondary outcomes

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

    Effect on Gingival recession

    Time frame: 12 weeks

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

    Effect on Gingival recession

    Time frame: 24 weeks

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Study locations

1 site
  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, China
08

References and documents

Publications

  • Wang Y, Yan F, Chen L, Zhao L, Liu M, Ge S, Chen CY, Kim DM, Shu R. Crosslinked Versus Non-Crosslinked Resorbable Collagen Membranes for Periodontal Regeneration: A Multicenter, Randomized, Double-Blind, Non-Inferiority Clinical Trial. J Periodontal Res. 2025 Nov;60(11):1086-1100. doi: 10.1111/jre.13382. Epub 2025 Jan 12. PubMed 39799466 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04851847
Lead sponsor
Collagen Matrix
Responsible party
Sponsor
First posted
Apr 21, 2021
Start date
Jun 10, 2021
Primary completion
Jul 20, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Mar 9, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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