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Completed

NCT Number: NCT03386877

Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIR Dental school Turin University, Turin, Piedmont, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

periodontal regeneration

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2017
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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