Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

• ClinicalTrials.gov Identifier: NCT03386877
• Recruitment Status: Completed
• First Posted: December 29, 2017
• Last Update Posted: December 29, 2017
• Sponsor: University of Turin, Italy
• Information provided by (Responsible Party): Francesco Ferrarotti, University of Turin, Italy

Tracking Information

• First Submitted Date: December 15, 2017
• First Posted Date: December 29, 2017
• Last Update Posted Date: December 29, 2017
• Actual Study Start Date: January 25, 2016
• Actual Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2017)

Radiographic bone fill [ Time Frame: 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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 20, 2017)

• Probing depth reduction [ Time Frame: 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 [ Time Frame: 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)
• Recession reduction [ Time Frame: 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)
• Official Title: Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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

Study Arms

• Experimental: Dental pulp stem cells
  Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge
  Intervention: Procedure: periodontal regeneration
• Active Comparator: coagulum
  control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone
  Intervention: Procedure: periodontal regeneration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2017): 29
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 28, 2017
• Actual Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT03386877
• Other Study ID Numbers: UTurin stem cell RCT
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Francesco Ferrarotti, University of Turin, Italy
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Turin, Italy
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mario Aimetti; Turin University

• PRS Account: University of Turin, Italy
• Verification Date: December 2017