Dental CariesPhase 2NCT03052842
A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application
A Phase 2 study testing C16G2 Strip in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- C16G2 Strip
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Feb 2017to 5 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and females, 12-75 years of age
- Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent
- Female subjects of childbearing potential must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
- Negative urine pregnancy test in all females of childbearing potential (past menarche)
- Male subjects of sexual activity age: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
- Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (general, extraoral, head and neck) during Screening Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the medical monitor on a case-by-case basis.
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- Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants
- Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
- Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
- Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
- Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
- Willing and able to comply with oral hygiene and diet instructions
- Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times
Who cannot join
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and are not required to be repeated at Screening
- Partially erupted teeth where the entire crown is not erupted or an operculum is present
- Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspicious or confirmed)
- Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets.
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- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, beginning 30 days prior to Screening until the end of study participation
- Medical history indicating the woman is pregnant, breastfeeding/lactating or has a positive urine pregnancy test
- Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded)
- Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jacqueline Kleven, DDS
Bedford, Texas, 76021
Anthony Henegar, DDS, PA
Irving, Texas, 75063
John F. Pittaway, DMD
Kalispell, Montana, 59901
About this study
Official title: A Phase 2, Single-blind, Randomized, Placebo-controlled Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Strip Administered in Multiple Doses to Adolescent and Adult Dental Subjects
Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries..
Read the detailed description
A single-blind, randomized, placebo-controlled, phase 2 study to evaluate oral microbiology and safety of multiple C16G2 Strip applications in male and female dental subjects 12-75 years of age.
The study will compare multiple study drug administrations of 9.2 mg, 18.4 mg, and 36.8 mg C16G2 Strip or Placebo in Study Arms 1 through 3, respectively. Enrollment of subjects in Study Arms 1 through 3 will occur sequentially in an ascending dose-escalation manner. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2. Subjects will receive 11 doses administered over approximately two weeks. Each subject will receive a single dose on Day 0, followed by 5 days of AM and PM dosing starting on Day 7. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 1 month after the last study drug administration.
Clinic visits include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation \& Baseline Visit 3, Follow-up Visits 4-7 (Safety and Microbiology), Visits 8-17 (Study Drug Administration), Follow-up Visits 18-20 (Safety and Microbiology) and Follow-up Visits 21-22 (Microbiology only).
- Conditions
- Dental Caries
- Being tested
- C16G2 Strip, Placebo Strip
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C16G2 StripDrug
Antimicrobial Peptide
Placebo StripOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A: 9.2 mg C16G2 | Experimental | Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. Receives: Drug: C16G2 Strip |
| Arm 1B: 9.2 mg Placebo | Placebo comparator | Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. Receives: Other: Placebo Strip |
| Arm 2A: 18.4 mg C16G2 | Experimental | Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. Receives: Drug: C16G2 Strip |
| Arm 2B: 18.4 mg Placebo | Placebo comparator | Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. Receives: Other: Placebo Strip |
| Arm 3A: 36.8 mg C16G2 | Experimental | Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Receives: Drug: C16G2 Strip |
| Arm 3B: 36.8 mg Placebo | Placebo comparator | Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Receives: Other: Placebo Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Activity of C16G2
To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.
Measured: Measured up to 1 months post last study drug administration
Total Oral Bacterial Levels
To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2.
Measured: Measured up to 1 months post last study drug administration
Secondary outcomes (1)
To Evaluate the Safety and Tolerability of Multiple C16G2
Safety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken.
Measured: Up to 1 week post last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start9 Feb 2017
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Three dose groups will be enrolled in an ascending dose escalation manner
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vantage Data Designs, Inc., E Squared Trials and Registries, Inc., Agility Clinical, Inc.
- Responsible party
- Sponsor
- Investigators
- John Pittaway, DMD, Principal investigator, Plaza West II Dental Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052842
- Sponsor's protocol ID
- C3J16-S205-00
- Status last verified
- Dec 2022
- First submitted
- 10 Feb 2017
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-blind, Randomized, Placebo-controlled Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Strip Administered in Multiple Doses to Adolescent and Adult Dental Subjects
- ClinicalTrials.gov ID
- NCT03052842
- Acronym / sponsor ID
- C3J16-S205-00
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vantage Data Designs, Inc., E Squared Trials and Registries, Inc., Agility Clinical, Inc.
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries..
Detailed description
A single-blind, randomized, placebo-controlled, phase 2 study to evaluate oral microbiology and safety of multiple C16G2 Strip applications in male and female dental subjects 12-75 years of age.
The study will compare multiple study drug administrations of 9.2 mg, 18.4 mg, and 36.8 mg C16G2 Strip or Placebo in Study Arms 1 through 3, respectively. Enrollment of subjects in Study Arms 1 through 3 will occur sequentially in an ascending dose-escalation manner. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2. Subjects will receive 11 doses administered over approximately two weeks. Each subject will receive a single dose on Day 0, followed by 5 days of AM and PM dosing starting on Day 7. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 1 month after the last study drug administration.
Clinic visits include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation \& Baseline Visit 3, Follow-up Visits 4-7 (Safety and Microbiology), Visits 8-17 (Study Drug Administration), Follow-up Visits 18-20 (Safety and Microbiology) and Follow-up Visits 21-22 (Microbiology only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Three dose groups will be enrolled in an ascending dose escalation manner
| Arm | Type | Receives |
|---|---|---|
| Arm 1A: 9.2 mg C16G2 | Experimental | Drug: C16G2 StripStudy subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 1B: 9.2 mg Placebo | Placebo comparator | Other: Placebo StripStudy subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 2A: 18.4 mg C16G2 | Experimental | Drug: C16G2 StripStudy subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 2B: 18.4 mg Placebo | Placebo comparator | Other: Placebo StripStudy subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm. |
| Arm 3A: 36.8 mg C16G2 | Experimental | Drug: C16G2 StripStudy subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). |
| Arm 3B: 36.8 mg Placebo | Placebo comparator | Other: Placebo StripStudy subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females, 12-75 years of age
- Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent
- Female subjects of childbearing potential must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
- Negative urine pregnancy test in all females of childbearing potential (past menarche)
- Male subjects of sexual activity age: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination
Key exclusion criteria (10 listed)
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and are not required to be repeated at Screening
- Partially erupted teeth where the entire crown is not erupted or an operculum is present
- Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspicious or confirmed)
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 |
|---|---|---|
| C16G2 StripAntimicrobial Peptide | Drug | Arm 1A: 9.2 mg C16G2, Arm 2A: 18.4 mg C16G2, Arm 3A: 36.8 mg C16G2 |
| Placebo StripPlacebo | Other | Arm 1B: 9.2 mg Placebo, Arm 2B: 18.4 mg Placebo, Arm 3B: 36.8 mg Placebo |
Primary outcome
Antimicrobial Activity of C16G2
Time frame: Measured up to 1 months post last study drug administration
To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.
Total Oral Bacterial Levels
Time frame: Measured up to 1 months post last study drug administration
To assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2.
1 secondary outcome
To Evaluate the Safety and Tolerability of Multiple C16G2
Time frame: Up to 1 week post last study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Pittaway, DMD principal investigator
Plaza West II Dental Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C16G2 Strip in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 3 sites 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 13 inclusion and 10 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antimicrobial Activity of C16G2 (time frame: Measured up to 1 months post last study drug administration). The study lists 2 primary outcomes in all. 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 22 Dec 2022.