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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04851847
• Other study ID #: D20190472-P
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2022
• Source: Collagen Matrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: August 1, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Device:
• Guided Tissue Regeneration (GTR)
Use of resorbable collagen membrane to treat periodontal intrabony defects.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Collagen Matrix

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of CAL at 12 weeks after surgery	Assessment of clinical attachment level	12 weeks
Primary	The change of CAL at 24 weeks after surgery	Assessment of clinical attachment level	24 weeks
Primary	The change of PD at 12 weeks after surgery	Assessment of Probing Depth	12 weeks
Primary	The change of PD at 24 weeks after surgery	Assessment of Probing Depth	24 weeks
Secondary	The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.	Effect on Gingival recession	12 weeks
Secondary	The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.	Effect on Gingival recession	24 weeks