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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MatrixflexTM resorbable collagen membrane | Experimental | Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects |
|
| control group membrane | Active Comparator | Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Tissue Regeneration (GTR) | Device | Use of resorbable collagen membrane to treat periodontal intrabony defects. |
|
| 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 |
| 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39799466 | Derived | 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. |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D048091 | Guided Tissue Regeneration |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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Effect on Gingival recession
| 24 weeks |