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Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
periodontal regeneration
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CIR dental school
  • CIR Dental school Turin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dental pulp stem cells

coagulum

Arm Description

Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge

control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Probing depth reduction
Probing depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Clinical attachment gain
Clinical attachment level is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Recession reduction
Recession depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Full Information

First Posted
December 15, 2017
Last Updated
December 20, 2017
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03386877
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 25, 2016 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental pulp stem cells
Arm Type
Experimental
Arm Description
Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge
Arm Title
coagulum
Arm Type
Active Comparator
Arm Description
control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone
Intervention Type
Procedure
Intervention Name(s)
periodontal regeneration
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiographic bone fill
Description
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)
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
Probing depth reduction
Description
Probing depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
baseline, 6 and 12 months
Title
Clinical attachment gain
Description
Clinical attachment level is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
baseline, 6 and 12 months
Title
Recession reduction
Description
Recession depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
baseline, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti
Organizational Affiliation
Turin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIR dental school
City
Torino
State/Province
Piedmont
ZIP/Postal Code
10126
Country
Italy
Facility Name
CIR Dental school Turin University
City
Turin
State/Province
Piedmont
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

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