Periodontal DiseasesPhase 1/2NCT02523651
Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy
A Phase 1/2 study testing DPSC injection in people with Periodontal Diseases, run by Songlin Wang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- DPSC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of periodontal disease will be based on clinical assessment of:
- Quigley-Hein index (QHI)
- Bleeding on Probing (BoP)
- Pocket Probing Depth (PD)
- gingival recession (GR)
- Clinical Attachment Level (CAL)
- furcation involvement,and
- radiographical assessment. All patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage.
Who cannot join
- Pregnant,
- smokers,
- immunosuppressed or diabetes patients,
- patients exhibit gingival hypertrophy,
- require premedication, and
- who have been taking systemic anti-inflammatory medications, or
- have taken antibiotics or
- received periodontal instrumentation within 6 months prior to the study, will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Capital Medical University School of Stomatology
Beijing, Beijing Municipality, 100050
Jingchao Hu, Ph.D, +86 13716607107, hujingchao117@hotmail.com
About this study
Official title: Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.
Read the detailed description
This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.
- Conditions
- Periodontal Diseases
- Being tested
- DPSC injection, Placebo
- Keywords
- Periodontal Diseases, Bone Regeneration, Dental Pulp Stem Cell
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPSC injectionGenetic
A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
PlaceboOther
A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| DPSC injection | Experimental | 20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing. Receives: Genetic: DPSC injection |
| Placebo control | Placebo comparator | 20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
Measured: Baseline and 1 year after intervention.
Secondary outcomes (4)
Quigley-Hein plaque index (QHI)
Measured: Baseline
Change from Baseline Bleeding on probing (BoP) at 1 year
Measured: Baseline and 1 year after intervention.
Change from Baseline Probing depth (PD) at 1 year
Measured: Baseline and 1 year after intervention.
Change from Baseline Clinical attachment level (CAL) at 1 year
Measured: Baseline and 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Songlin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Songlin Wang, Capital Medical University
- Investigators
- Songlin Wang, Ph.D, Study director, Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523651
- Sponsor's protocol ID
- CapitalMedicalU-1
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
- ClinicalTrials.gov ID
- NCT02523651
- Acronym / sponsor ID
- CapitalMedicalU-1
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal Diseases, Bone Regeneration, Dental Pulp Stem Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Songlin WangUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- 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 purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.
Detailed description
This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.
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 |
|---|---|---|
| DPSC injection | Experimental | Genetic: DPSC injection20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing. |
| Placebo control | Placebo comparator | Other: Placebo20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosis of periodontal disease will be based on clinical assessment of:
Key exclusion criteria (8 listed)
- Pregnant,
- smokers,
- immunosuppressed or diabetes patients,
- patients exhibit gingival hypertrophy,
- require premedication, and
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 |
|---|---|---|
| DPSC injectionA 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing. | Genetic | DPSC injection |
| PlaceboA 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing. | Other | Placebo control |
Primary outcome
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
Time frame: Baseline and 1 year after intervention.
4 secondary outcomes
Quigley-Hein plaque index (QHI)
Time frame: Baseline
Change from Baseline Bleeding on probing (BoP) at 1 year
Time frame: Baseline and 1 year after intervention.
Change from Baseline Probing depth (PD) at 1 year
Time frame: Baseline and 1 year after intervention.
Change from Baseline Clinical attachment level (CAL) at 1 year
Time frame: Baseline and 1 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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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.
Songlin Wang, Ph.D study director
Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DPSC injection in people with Periodontal Diseases, run by Songlin Wang at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songlin Wang, Ph.D (+86 13601324511, slwang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year (time frame: Baseline and 1 year after intervention.). 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 14 Aug 2015.