Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Torino, Piedmont, Italy, 10126
      • CIR Dental School
    • Turin, Piedmont, Italy, 10126
      • CIR Dental school Turin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dental pulp stem cells; Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge	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
ACTIVE_COMPARATOR: coagulum; control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Mario Aimetti, Turin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2016
• Primary Completion (ACTUAL): April 28, 2017
• Study Completion (ACTUAL): April 28, 2017

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (ACTUAL): December 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: UTurin stem cell RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No