Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: periodontal regeneration

• Registration Number: NCT03386877
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01-25
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-29
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coagulum	periodontal regeneration	control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone
Dental pulp stem cells	periodontal regeneration	Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge

Primary Outcome Measures

Name	Time	Method
Radiographic bone fill	baseline and 12 months	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)

Secondary Outcome Measures

Name	Time	Method
Recession reduction	baseline, 6 and 12 months	Recession depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Probing depth reduction	baseline, 6 and 12 months	Probing depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Clinical attachment gain	baseline, 6 and 12 months	Clinical attachment level is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Trial Locations

Locations (2)

CIR Dental school Turin University; 🇮🇹 Turin, Piedmont, Italy

CIR dental school; 🇮🇹 Torino, Piedmont, Italy