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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Periodontal Diseases Intrabony Defects Guided Tissue Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MatrixflexTM resorbable collagen membrane

Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects

Group Type EXPERIMENTAL

Guided Tissue Regeneration (GTR)

Intervention Type DEVICE

Use of resorbable collagen membrane to treat periodontal intrabony defects.

control group membrane

Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects

Group Type ACTIVE_COMPARATOR

Guided Tissue Regeneration (GTR)

Intervention Type DEVICE

Use of resorbable collagen membrane to treat periodontal intrabony defects.

Interventions

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Guided Tissue Regeneration (GTR)

Use of resorbable collagen membrane to treat periodontal intrabony defects.

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No