Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

Study Overview
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: periodontal regeneration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental pulp stem cells<br>Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge | Procedure: periodontal regeneration<br>* 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<br>|
| Active Comparator: coagulum<br>control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone | Procedure: periodontal regeneration<br>* 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<br>|

What is the study measuring?
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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 |