Periodontal DiseasesNCT03386877
Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)
A study testing periodontal regeneration in people with Periodontal Diseases, run by University of Turin, Italy at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- periodontal regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Jan 2016to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
CIR Dental school Turin University
Turin, Piedmont, 10126
CIR dental school
Turin, Piedmont, 10126
About this study
Official title: Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- periodontal regeneration
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal regenerationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Dental pulp stem cells | Experimental | Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge Receives: Procedure: periodontal regeneration |
| coagulum | Active comparator | control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone Receives: Procedure: periodontal regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 12 months
Secondary outcomes (3)
Probing depth reduction
Probing depth is assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: 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)
Measured: 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)
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start25 Jan 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Ferrarotti, University of Turin, Italy
- Investigators
- Mario Aimetti, Principal investigator, Turin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386877
- Sponsor's protocol ID
- UTurin stem cell RCT
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03386877
- Acronym / sponsor ID
- UTurin stem cell RCT
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental pulp stem cells | Experimental | Procedure: periodontal regenerationTest sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge |
| coagulum | Active comparator | Procedure: periodontal regenerationcontrol sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of advanced chronic periodontitis
- FMPS<20%
- FMBS<20%
- infrabony defect >2mm
- Probing depth >5mm
Key exclusion criteria (8 listed)
- smoking
- controindicazion for periodontal surgery
- systemic diseases affecting periodontal healing
- pregnancy an lactation
- fixed orthodontic appliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal regenerationDefects 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 | Procedure or surgery | Dental pulp stem cells, coagulum |
Primary outcome
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)
3 secondary outcomes
Probing depth reduction
Time frame: baseline, 6 and 12 months
Clinical attachment gain
Time frame: baseline, 6 and 12 months
Recession reduction
Time frame: baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Aimetti principal investigator
Turin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal regeneration in people with Periodontal Diseases, run by University of Turin, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone fill (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017; AzTrials last refreshed its copy on 31 Oct 2026.