PeriodontitisPhase 1NCT00689143
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
A Phase 1 study testing sargramostim in people with Periodontitis, run by Innoventus Project AB at 1 site in Sweden.
Trial summary
This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- sargramostim
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Oct 2008
- Phase
- Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (male or female) referred to Dept of Oral \& Maxillofacial surgery to have a lower wisdom tooth surgically extracted
- ≥ 20 and ≤ 40 years of age
- Analysis results of blood status within normal reference ranges
- Ability to attend the scheduled visits for evaluation procedures
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- Signed informed consent
Who cannot join
- Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
- An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
- Current use of anti-coagulant therapy or within 10 days from baseline
- Current use of immunomodulating medication
- Current use of corticosteroids (Amendment 1: topical use permitted).
- Current use of lithium.
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- Use of tobacco products or nicotine replacement therapy
- Alcohol or drug abuse
- HIV or hepatitis infection
- Pregnancy or lactation
- Participation in another clinical study on medicinal products at the time of inclusion
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days
This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.
Read the detailed description
It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.
- Conditions
- Periodontitis
- Being tested
- sargramostim
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimDrug
Also called GM-CSF, Leukine
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
Secondary outcomes (1)
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innoventus Project AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Investigators
- Jan Hirsch, Prof., Principal investigator, Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689143
- Sponsor's protocol ID
- IPPIS-0604
- Status last verified
- Oct 2008
- First submitted
- 29 May 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days
- ClinicalTrials.gov ID
- NCT00689143
- Acronym / sponsor ID
- IPPIS-0604
- Conditions
- Periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Innoventus Project ABIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Jun 2008 (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.
This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.
Detailed description
It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy individuals (male or female) referred to Dept of Oral \& Maxillofacial surgery to have a lower wisdom tooth surgically extracted
- ≥ 20 and ≤ 40 years of age
- Analysis results of blood status within normal reference ranges
- Ability to attend the scheduled visits for evaluation procedures
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
Key exclusion criteria (12 listed)
- Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
- An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
- Current use of anti-coagulant therapy or within 10 days from baseline
- Current use of immunomodulating medication
- Current use of corticosteroids (Amendment 1: topical use permitted).
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 |
|---|---|---|
| sargramostimAlso: GM-CSF, Leukine | Drug | – |
Primary outcome
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
1 secondary outcome
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
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 Oct 2008.
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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.
Jan Hirsch, Prof. principal investigator
Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sargramostim in people with Periodontitis, run by Innoventus Project AB at 1 site in Sweden.
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 12 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 Oct 2008. 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 Sweden. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days. 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 Oct 2008; AzTrials last refreshed its copy on 8 Nov 2026.