Status:
UNKNOWN
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
Lead Sponsor:
Collagen Matrix
Conditions:
Periodontal Diseases
Intrabony Defects
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04851847
Start Date
June 10 2021
End Date
August 1 2022
Last Update
March 9 2022
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China