Periodontal Diseases
Conditions
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.
Interventions
PROCEDUREperiodontal 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
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone fill | 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
| Measure | Time frame | Description |
|---|---|---|
| Probing depth reduction | 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) |
| Clinical attachment gain | 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) |
| Recession reduction | 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) |
Countries
Italy
Outcome results
None listed