NCT03137979

Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis

The Safety and Efficacy Evaluation of Gingiva Mesenchymal Stem Cells Transplantation in Chronic Periodontitis Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hebei Medical University · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy for Chronic Adult Periodontitis.

Detailed description

Periodontitis featured by the progressive destruction loss of support tissues around the teeth has become a prevalent disease affecting the life quality of the adults. Although conventional periodontal treatment including open flap debridement and drug support therapy display reduced pocket depth and inflammation, the functional regeneration of the lost tissue and the repair of alveolar bone are insufficient. Gingiva mesenchymal stem cells (GMSCs) are multipotent cells possess the capacity of multilineage differentiation and have become an attractive optional treatment method for the regeneration of periodontal tissues and function. Therefore, GMSCs will be selected as seed cells to treat periodontitis. This study will recruit 30 patients which will be divided into three groups. 10 patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. 10 patients in group B will only receive collagen scaffolds devoid of GMSCs after open flap debridement. 10 patients in group C will only undergo an open flap debridement. This study will test the safety and efficacy of GMSCs implantation in chronic adult periodontitis through alveolous bone reproduction and other clinical parameters.

Conditions

• Periodontitis

Interventions

Type	Name	Description
BIOLOGICAL	GMSCs and collagen scaffolds	Patients in this group were given GMSCs and collagen scaffolds.
BIOLOGICAL	Collagen scaffolds	Patients in this group were given collagen scaffolds.
PROCEDURE	Open flap debridement	The patients in this group will only receive the treatment of open flap debridement.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2017-05-03
• Last updated: 2017-05-03

Locations

1 site across 1 country: China