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Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

NCT ID: NCT03386877

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-25

Study Completion Date

2017-04-28

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dental pulp stem cells

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

Group Type EXPERIMENTAL

periodontal regeneration

Intervention Type PROCEDURE

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

coagulum

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

Group Type ACTIVE_COMPARATOR

periodontal regeneration

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Francesco Ferrarotti

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Aimetti

Role: PRINCIPAL_INVESTIGATOR

Turin University

Locations

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CIR Dental school Turin University

Turin, Piedmont, Italy

Site Status

CIR dental school

Turin, Piedmont, Italy

Site Status

Countries

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Italy

Other Identifiers

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UTurin stem cell RCT

Identifier Type: -

Identifier Source: org_study_id