GingivitisPhase 1NCT02071199
Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)
A Phase 1 study testing 1X ACCS (Amnion-derived Cellular Cytokine Solution), Normal saline and 0.3X ACCS in people with Gingivitis, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- 1X ACCS (Amnion-derived Cellular Cytokine Solution), Normal saline and 0.3X ACCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good general health
- ages 18-70 years
- minimum of 20 natural teeth
- modified gingival index score of 2.0 or greater and >40 percent bleeding sites at initial presentation.
Who cannot join
- presence of orthodontic appliance
- soft or hard tissue tumor of the oral cavity
- carious lesion requiring immediate treatment
- participation in another clinical trial within 30 days
- pregnant or breast-feeding women
- women of child-bearing potential refusing to use an acceptable method of birth control
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- antibiotic therapy within the last 30 days
- chronic use (> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID). Any use of steroids. Low dose (<325 mg) aspirin is allowed.
- immune-compromised subjects
- subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2X the upper limit of normal.
- any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial
The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
Read the detailed description
This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.
- Conditions
- Gingivitis
- Being tested
- 1X ACCS (Amnion-derived Cellular Cytokine Solution), Normal saline, 0.3X ACCS
- Keywords
- Gingivitis, Periodontitis, ACCS
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1X ACCS (Amnion-derived Cellular Cytokine Solution)Drug
Also called ACCS
1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
Normal salineDrug
Also called saline placebo
Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
0.3X ACCSDrug
Also called Diluted ACCS
0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low dose 0.3X ACCS | Experimental | 20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks Receives: Drug: 0.3X ACCS |
| High dose 1X ACCS | Experimental | 20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks Receives: Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution) |
| Normal saline | Placebo comparator | 20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse/serious adverse events
Measured: End of two weeks of treatment and at two weeks follow-up visit
Secondary outcomes (6)
Probing pocket depth
Depth will be measured at six sites per tooth
Measured: Bseline and after two weeks of treatment
Modified gingival index
Gingival index will be measured at six sites per tooth
Measured: Baseline and after two weeks of treatment
Bleeding on probing
Bleeding will be measured at six sites per tooth
Measured: Baseline and after two weeks of treatment
Plaque index
Only the gingival third of the tooth will be evaluated
Measured: Baseline and after two weeks of treatment
Microbial analysis
6 teeth will be sampled
Measured: Baseline and after two weeks of treatment
Cytokine analysis
Inflammatory cytokines will be sampled in crevicular fluid
Measured: Baseline and after two weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L Steed, MD, Study director, Noveome Biotherapeutics, formerly Stemnion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071199
- Sponsor's protocol ID
- ST-04-13
- Status last verified
- Nov 2016
- First submitted
- 21 Feb 2014
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial
- ClinicalTrials.gov ID
- NCT02071199
- Acronym / sponsor ID
- ST-04-13
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Periodontitis, ACCS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Feb 2014 (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 oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
Detailed description
This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose 0.3X ACCS | Experimental | Drug: 0.3X ACCS20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks |
| High dose 1X ACCS | Experimental | Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution)20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks |
| Normal saline | Placebo comparator | Drug: Normal saline20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- good general health
- ages 18-70 years
- minimum of 20 natural teeth
- modified gingival index score of 2.0 or greater and >40 percent bleeding sites at initial presentation.
Key exclusion criteria (11 listed)
- presence of orthodontic appliance
- soft or hard tissue tumor of the oral cavity
- carious lesion requiring immediate treatment
- participation in another clinical trial within 30 days
- pregnant or breast-feeding women
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 |
|---|---|---|
| 1X ACCS (Amnion-derived Cellular Cytokine Solution)Also: ACCS1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks | Drug | High dose 1X ACCS |
| Normal salineAlso: saline placeboSaline will be applied to the gingival margin daily 5 days per week for 2 weeks | Drug | Normal saline |
| 0.3X ACCSAlso: Diluted ACCS0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks | Drug | Low dose 0.3X ACCS |
Primary outcome
Incidence of adverse/serious adverse events
Time frame: End of two weeks of treatment and at two weeks follow-up visit
6 secondary outcomes
Probing pocket depth
Time frame: Bseline and after two weeks of treatment
Modified gingival index
Time frame: Baseline and after two weeks of treatment
Bleeding on probing
Time frame: Baseline and after two weeks of treatment
Plaque index
Time frame: Baseline and after two weeks of treatment
Microbial analysis
Time frame: Baseline and after two weeks of treatment
Cytokine analysis
Time frame: Baseline and after two weeks of therapy
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 Nov 2016.
- Individual participant dataSharing planned: No
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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.
David L Steed, MD study director
Noveome Biotherapeutics, formerly Stemnion
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 1X ACCS (Amnion-derived Cellular Cytokine Solution), Normal saline and 0.3X ACCS in people with Gingivitis, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
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 4 inclusion and 11 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 Nov 2016. 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 United States. 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 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?
Incidence of adverse/serious adverse events (time frame: End of two weeks of treatment and at two weeks follow-up visit). 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 Nov 2016.