Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

NCT03386877 | Completed DMC

• 1 other identifier: UTurin stem cell RCT
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Probing depth reduction

  baseline, 6 and 12 months

• Clinical attachment gain

  baseline, 6 and 12 months

• Recession reduction

  baseline, 6 and 12 months

Study Arms (2)

Dental pulp stem cells

EXPERIMENTAL

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

Procedure: periodontal regeneration

coagulum

ACTIVE COMPARATOR

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

Procedure: periodontal regeneration

Interventions

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

Dental pulp stem cells; coagulum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (2)

CIR Dental school Turin University

Turin, Piedmont, 10126, Italy

Location

CIR dental school

Turin, Piedmont, 10126, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Guided Tissue Regeneration, Periodontal

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guided Tissue Regeneration; Plastic Surgery Procedures; Surgical Procedures, Operative; Oral Surgical Procedures; Dentistry; Periodontics

Study Officials

• Mario Aimetti

  Turin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: January 25, 2016
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

IT (2)