Dental CariesPhase 2C3J17-206-00NCT03196219
A Phase 2 Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip in Adolescent and Adult Subjects
A Phase 2 study testing C16G2 in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 10 Jan 2018
- 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.
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- 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.
- 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)
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- Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets. Note: Partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study
- Use of systemic antibiotics, topical oral antibiotics, any immunosuppressant therapy, and steroids, 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)
- Participation in a previous C16G2 clinical trial having received either C16G2 Strip, C16G2 Varnish or Placebo Varnish
- 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
1 site in 1 country.
About this study
Official title: A Phase 2, Open-label and Single-Blind Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip Administered in Multiple Doses to Adolescent and Adult Dental Subjects
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age. The study will compare multiple study drug administrations of C16G2 Varnish and/or C16G2 Strip in three study arms.
In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for up to 2 months after the last study drug administration.
Read more
Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish administrations. Subjects will be followed for microbiology for up to 2 months after the last study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2 Varnish, 6 subjects receiving Placebo).
Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to 2 months after the last study drug administration.
Read the detailed description
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age.
The study will compare multiple study drug administrations of 13.6 milligrams (mg) of C16G2 Varnish and 9.2 mg of C16G2 Strip in three study arms. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2.
In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. C16G2 Varnish will be applied with a small brush typically used in dental varnish administration. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects receiving C16G2 Varnish, 6 subjects receiving Placebo). To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to two week post last study drug administration from Study Arm 2.
If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Clinic visits in Study Arm 1 include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish Dosing at Visit 3, Visits 4 \& 5 (C16G2 Varnish Administration), Visits 6-19 (AM \& PM C16G2 Strip Administration), Follow-up Visits 20 \& 21 (Safety and Microbiology) and Follow-up Visits 22-24 (Microbiology only).
Clinic visits in Study Arm 2 include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish or Placebo Dosing at Visit 3, Visits 4-9 (C16G2 Varnish or Placebo Administration), Follow-up Visits 10 \& 11 (Safety and Microbiology) and Follow-up Visits 12-14 (Microbiology only).
Clinic visits in Study Arm 3 include Clinic Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish Dosing at Visit 3, Visits 4-12 (C16G2 Varnish Administration), Follow-up Visits 13 \& 14 (Safety and Microbiology) and Follow-up Visits 15-17 (Microbiology only).
- Conditions
- Dental Caries
- Being tested
- C16G2, Placebo
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C16G2Drug
Also called Antimicrobial Peptide
C16G2
PlaceboDrug
Varnish Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish | Experimental | Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. Receives: Drug: C16G2 |
| Arm 2A: Single-Blind C16G2 Varnish | Experimental | Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). Receives: Drug: C16G2 |
| Arm 2B: Single-Blind Placebo | Placebo comparator | Twelve subjects will be enrolled in a single-blind manner. Subjects will receive Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). Receives: Drug: Placebo |
| Arm 3: Open-Enrollment Single Dose C16G2 Varnish | Experimental | If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses. Receives: Drug: C16G2 |
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: Evaluated over up to 2 months
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: 1 day post last study drug administration
Secondary outcomes (1)
To Evaluate the Safety 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 7 days 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 posted22 Jun 2017
- Study start7 Jul 2017
- Primary completion22 Nov 2017
- Study completion10 Jan 2018
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
- Study Arms 1 and 2 will be enrolled in parallel followed by Study Arm 3.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Pittaway, DMD, Principal investigator, Plaza West II Dental Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196219
- Sponsor's protocol ID
- C3J17-206-00
- Acronym
- C3J17-206-00
- Status last verified
- Dec 2022
- First submitted
- 21 Jun 2017
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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, Open-label and Single-Blind Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Varnish and Strip Administered in Multiple Doses to Adolescent and Adult Dental Subjects
- ClinicalTrials.gov ID
- NCT03196219
- Acronym / sponsor ID
- C3J17-206-00 / C3J17-206-00
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 22 Jun 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.
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age. The study will compare multiple study drug administrations of C16G2 Varnish and/or C16G2 Strip in three study arms.
In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for up to 2 months after the last study drug administration.
Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish administrations. Subjects will be followed for microbiology for up to 2 months after the last study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2 Varnish, 6 subjects receiving Placebo).
Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to 2 months after the last study drug administration.
Detailed description
An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and tolerability of multiple C16G2 Varnish and Strip applications in male and female dental subjects 12-75 years of age.
The study will compare multiple study drug administrations of 13.6 milligrams (mg) of C16G2 Varnish and 9.2 mg of C16G2 Strip in three study arms. Before dosing of study drug, eligible subjects will receive professional dental prophylaxis between Days -7 and -2.
In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. C16G2 Varnish will be applied with a small brush typically used in dental varnish administration. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects receiving C16G2 Varnish, 6 subjects receiving Placebo). To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to two week post last study drug administration from Study Arm 2.
If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses. To evaluate the durability of S. mutans suppression, study subjects will be followed for microbiology for up to 2 months after the last study drug administration.
Clinic visits in Study Arm 1 include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish Dosing at Visit 3, Visits 4 \& 5 (C16G2 Varnish Administration), Visits 6-19 (AM \& PM C16G2 Strip Administration), Follow-up Visits 20 \& 21 (Safety and Microbiology) and Follow-up Visits 22-24 (Microbiology only).
Clinic visits in Study Arm 2 include Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish or Placebo Dosing at Visit 3, Visits 4-9 (C16G2 Varnish or Placebo Administration), Follow-up Visits 10 \& 11 (Safety and Microbiology) and Follow-up Visits 12-14 (Microbiology only).
Clinic visits in Study Arm 3 include Clinic Visit 1 (Screening/Days -30 to -1), Visit 2 (Prophylaxis/Day -7 to -2), Eligibility Confirmation, Baseline \& First C16G2 Varnish Dosing at Visit 3, Visits 4-12 (C16G2 Varnish Administration), Follow-up Visits 13 \& 14 (Safety and Microbiology) and Follow-up Visits 15-17 (Microbiology only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Study Arms 1 and 2 will be enrolled in parallel followed by Study Arm 3.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish | Experimental | Drug: C16G2Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip. |
| Arm 2A: Single-Blind C16G2 Varnish | Experimental | Drug: C16G2Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). |
| Arm 2B: Single-Blind Placebo | Placebo comparator | Drug: PlaceboTwelve subjects will be enrolled in a single-blind manner. Subjects will receive Placebo applications over 7 days (Days 0, 2, 5 \& 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo). |
| Arm 3: Open-Enrollment Single Dose C16G2 Varnish | Experimental | Drug: C16G2If initiated, Study Arm 3 will enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2 Varnish over 10 days, for a total of 10 doses. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 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 (12 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
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 |
|---|---|---|
| C16G2Also: Antimicrobial PeptideC16G2 | Drug | Arm 1: Open-Enrollment Multiple Dose C16G2 Varnish, Arm 2A: Single-Blind C16G2 Varnish, Arm 3: Open-Enrollment Single Dose C16G2 Varnish |
| PlaceboVarnish Placebo | Drug | Arm 2B: Single-Blind Placebo |
Primary outcome
Antimicrobial Activity of C16G2
Time frame: Evaluated over up to 2 months
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: 1 day 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 of Multiple C16G2
Time frame: Up to 7 days 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.
- 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.
John Pittaway, DMD principal investigator
Plaza West II Dental Group
1 site 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 in people with Dental Caries, run by Armata Pharmaceuticals, Inc. 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 14 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 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 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 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: Evaluated over up to 2 months). 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; AzTrials last refreshed its copy on 29 Oct 2026.