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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases	Procedure: periodontal regeneration	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
• Actual Study Start Date: January 25, 2016
• Actual Primary Completion Date: April 28, 2017
• Actual Study Completion Date: April 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Italy

CIR dental school

Torino, Piedmont, Italy, 10126

CIR Dental school Turin University

Turin, Piedmont, Italy, 10126

Sponsors and Collaborators

University of Turin, Italy

Investigators

• Principal Investigator: Mario Aimetti; Turin University

More Information

• Responsible Party: Francesco Ferrarotti, Adjunct Professor, University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT03386877
• Other Study ID Numbers: UTurin stem cell RCT
• First Posted: December 29, 2017
• Last Update Posted: December 29, 2017
• Last Verified: December 2017

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

Additional relevant MeSH terms:

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases