UnknownNot Applicable

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

China174 participantsStarted 2021-06-10

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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 criteria

✕. 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;

What they're measuring

The change of CAL at 12 weeks after surgery

Timeframe: 12 weeks

The change of CAL at 24 weeks after surgery

Timeframe: 24 weeks

The change of PD at 12 weeks after surgery

Timeframe: 12 weeks

The change of PD at 24 weeks after surgery

Timeframe: 24 weeks

Trial details

NCT IDNCT04851847

SponsorCollagen Matrix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-20

View on ClinicalTrials.gov More Periodontal Diseases trials