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Gingiva Mesenchymal Stem Cells for Chronic Periodontitis
NCT03137979Phase 2
Key facts
- Status
- Unknown
- Start
- Jan 2017
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- Hebei Medical University
- Modality
- Stem Cell Therapies
- Conditions
- chronic periodontitis
01
Overview
Phase 2, randomised, open-label trial of gingiva-derived mesenchymal stem cells in chronic periodontitis (3 arms), sponsored by Hebei Medical University. Primary endpoint: The evaluation of alveolar bone regeneration at 6 months. Status: unknown.
02
Design
3 arms- Study design
- RandomizedOpen-label
Group A: GMSCs and collagen scaffolds
GMSCs seeded into collagen scaffolds at periodontal defects
Group B: collagen scaffolds
Collagen scaffolds implantation at periodontal defects
Group C: comparator
Open flap debridement only
03
Who it enrols
Adults aged 35-60 with chronic periodontitis, probing depth >= 6mm, attachment loss >= 3mm, and infrabony pocket >= 4mm, who have stable lesions after routine treatment. Excludes smokers (>10 cigs/day), diabetics, and those with significant systemic diseases.
04
Endpoints
Primary
The evaluation of alveolar bone regeneration
Secondary
Probing pocket depth
Attachment level
Gingival index
Tooth mobility degree
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