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

Not Applicable

• Conditions: Periodontal Diseases; Intrabony Defects; Guided Tissue Regeneration
• Interventions: Device: Guided Tissue Regeneration (GTR)

• Registration Number: NCT04851847
• Lead Sponsor: Collagen Matrix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-06-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2022-07-20
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MatrixflexTM resorbable collagen membrane	Guided Tissue Regeneration (GTR)	Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects
control group membrane	Guided Tissue Regeneration (GTR)	Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects

Primary Outcome Measures

Name	Time	Method
The change of CAL at 12 weeks after surgery	12 weeks	Assessment of clinical attachment level
The change of PD at 24 weeks after surgery	24 weeks	Assessment of Probing Depth
The change of CAL at 24 weeks after surgery	24 weeks	Assessment of clinical attachment level
The change of PD at 12 weeks after surgery	12 weeks	Assessment of Probing Depth

Secondary Outcome Measures

Name	Time	Method
The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.	12 weeks	Effect on Gingival recession
The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.	24 weeks	Effect on Gingival recession

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China