NCT04851847

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

April 14, 2021

Last Update Submit

March 8, 2022

Conditions

Periodontal DiseasesIntrabony DefectsGuided Tissue Regeneration

Keywords

resorbable collagen membrane

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

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

    12 weeks

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

    24 weeks

Study Arms (2)

MatrixflexTM resorbable collagen membrane

EXPERIMENTAL

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

Device: Guided Tissue Regeneration (GTR)

control group membrane

ACTIVE COMPARATOR

Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects

Device: Guided Tissue Regeneration (GTR)

Interventions

Guided Tissue Regeneration (GTR)DEVICE

Use of resorbable collagen membrane to treat periodontal intrabony defects.

MatrixflexTM resorbable collagen membranecontrol group membrane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Related Publications (1)

  • 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 Jan 12. doi: 10.1111/jre.13382. Online ahead of print.

    PMID: 39799466DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Guided Tissue Regeneration

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 21, 2021

Study Start

June 10, 2021

Primary Completion

July 20, 2022

Study Completion

August 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)