Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

Periodontal Diseases Clinical Trial

Official title:

Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386877
• Other study ID #: UTurin stem cell RCT
• Status: Completed
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 20, 2017
• Start date: January 25, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: December 2017
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.

Description:

In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of advanced chronic periodontitis

• FMPS<20%

• FMBS<20%

• infrabony defect >2mm

• Probing depth >5mm

• presence of 1 vital and intact tooth requiring an extraction as autologous source of DPSCs

Exclusion Criteria:

• smoking

• controindicazion for periodontal surgery

• systemic diseases affecting periodontal healing

• pregnancy an lactation

• fixed orthodontic appliance

• history of periodontal surgery at the experimental teeth

• prostethic restorations at the experimental teeth

• furcation defects

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Procedure:
• periodontal regeneration
Defects were accessed with the MIST In the test group the obtained micro-grafts enriched in DPSCs were endorsed onto a collagen sponge scaffold (Condress®, Istituto Gentili, Milano, Italy) to form a bio-complex. In the control group the collagen sponge was only hydrated using physiologic sterile solution. The collagen sponge with or without cells was provided to the masked surgeon who filled the intrabony defect. The flaps were repositioned and tension-free primary flap closure was obtained using horizontal internal mattress and interrupted sutures

Locations

Country	Name	City	State
Italy	CIR dental school	Torino	Piedmont
Italy	CIR Dental school Turin University	Turin	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic bone fill	Periapical standardized radiographs were taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)	baseline and 12 months
Secondary	Probing depth reduction	Probing depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	baseline, 6 and 12 months
Secondary	Clinical attachment gain	Clinical attachment level is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	baseline, 6 and 12 months
Secondary	Recession reduction	Recession depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	baseline, 6 and 12 months