Dental CariesPhase 2NCT02044081
Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults
A Phase 2 study testing C16G2 Rinse and C16G2 Gel in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- C16G2 Rinse and C16G2 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Phase 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible to participate if they meet the following criteria:
- Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed
- Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, 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, monogamous relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit.
- Male subjects only: 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, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening
- Have a minimum of six unrestored bicuspids and molars with less than 50% of molars and bicuspids having restorations, crowns, sealants or are missing
Show all 13Show fewer
- Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
- Demonstrated ability to swish 10 mL of water for 4 minutes
- Have a salivary and dental plaque S. mutans of 2.0 x 10^4 colony forming unit (CFU)s/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 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)
- Able to understand and sign the Informed Consent Form prior to initiation of study procedures
- Able to communicate with the Investigator/study site personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times
Who cannot join
- Subjects are excluded from participation if any of the following apply:
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by dental examination and standard radiographs).
- 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 or partial dentures, or orthodontic appliances, e.g. night guards, permanent retainers
Show all 11Show fewer
- Impaired salivary function (unable to provide 2 mL of stimulated saliva within 5 minutes)
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the Investigator could influence the study outcome, within 30 days prior to Screening
- Medical history indicating the woman is pregnant, breastfeeding/lactating or she 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Plaza West II Dental Group
Kalispell, Montana, 59901
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Administered in Multiple Oral Gel and/or Mouth Rinse Doses to Healthy Adult Subjects
The focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes.
Read the detailed description
The study will evaluate the safety of multiple study drug administrations as assessed by adverse event monitoring, oral cavity assessments, targeted physical exams and vital signs. The study will also assess the study drug's ability to selectively reduce or eliminate specific bacteria in the mouth by comparing a liquid and gel product applied in different modes, such as mouth rinse administration and gel application using a dental tray, electric toothbrush or manual toothbrush administered over 7 consecutive days. Subjects will be followed for approximately 8 days after the last study drug administration for safety and microbiology.
- Conditions
- Dental Caries
- Being tested
- C16G2 Rinse, Placebo, C16G2 Gel
- 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 RinseDrug
Active rinses are 1.6 mg/mL C16G2.
PlaceboDrug
Placebo is the vehicle without C16G2
C16G2 GelDrug
Active C16G2 Gel is 3.2 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Mouth Rinse Administration | Other | Day 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations. Receives: Drug: C16G2 Rinse; Drug: Placebo |
| Dental Tray Gel Administration | Other | Day 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations. Receives: Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel |
| Electric Toothbrush Gel Application | Other | Day 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations. Receives: Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel |
| Manual Toothbrush Gel Application | Other | Day 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations. Receives: Drug: C16G2 Rinse; Drug: Placebo; Drug: C16G2 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects.
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams (C16G2 subjects in the four study arms vs. placebo).
Measured: Screening, Baseline, Days 1-7, & Day 14
Secondary outcomes (2)
To assess the targeted antimicrobial activity of C16G2 gel and rinse applications as measured by a reduction of dental plaque and salivary Streptococcus mutans (S. mutans).
Saliva and dental plaque samples will be assessed at screening and Days 1, 7 and 14 for S. mutans (C16G2 subjects in the four study arms vs. placebo).
Measured: Screening, Baseline, Days 1, 7 & 14
To assess total bacteria in dental plaque and saliva post-study drug. administration
Total bacteria will be assessed at screening, baseline and Days 1, 7 and 14 (C16G2 subjects in the four study arms vs. placebo).
Measured: Screening, Baseline, Days 1, 7 & 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Marberger, DDS, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044081
- Sponsor's protocol ID
- C3J13-201-01
- Status last verified
- Jul 2019
- First submitted
- 9 Jan 2014
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Administered in Multiple Oral Gel and/or Mouth Rinse Doses to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02044081
- Acronym / sponsor ID
- C3J13-201-01
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Jan 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 focus of the study is to evaluate the safety of multiple study drug administrations and the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will compare a liquid and gel product applied in different modes.
Detailed description
The study will evaluate the safety of multiple study drug administrations as assessed by adverse event monitoring, oral cavity assessments, targeted physical exams and vital signs. The study will also assess the study drug's ability to selectively reduce or eliminate specific bacteria in the mouth by comparing a liquid and gel product applied in different modes, such as mouth rinse administration and gel application using a dental tray, electric toothbrush or manual toothbrush administered over 7 consecutive days. Subjects will be followed for approximately 8 days after the last study drug administration for safety and microbiology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mouth Rinse Administration | Other | Drug: C16G2 Rinse, Drug: PlaceboDay 0, three consecutive C16G2 or placebo rinse administrations followed by three single C16G2 or placebo rinse administrations. Days 1 to 6 two additional C16G2 or placebo rinse administrations. |
| Dental Tray Gel Administration | Other | Drug: C16G2 Rinse, Drug: Placebo, Drug: C16G2 GelDay 0, two C16G2 or placebo gel dental tray applications and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo dental tray applications and two C16G2 or placebo rinse administrations. |
| Electric Toothbrush Gel Application | Other | Drug: C16G2 Rinse, Drug: Placebo, Drug: C16G2 GelDay 0, four C16G2 or placebo gel administrations applied with an electric toothbrush and four C16G2 or placebo rinse administrations. Days 1 to 6, two C16G2 or placebo gel administrations applied with a electric toothbrush and two C16G2 or placebo rinse administrations. |
| Manual Toothbrush Gel Application | Other | Drug: C16G2 Rinse, Drug: Placebo, Drug: C16G2 GelDay 0, four C16G2 or Placebo gel administrations applied with a manual toothbrush and four C16G2 or Placebo rinse administrations. Days 1 to 6, two C16G2 or Placebo gel administrations applied with a electric toothbrush and two C16G2 or Placebo rinse administrations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females, 18-75 years of age, inclusive, at the time the Informed Consent Form is signed
- Female subjects of childbearing potential, defined as not surgically sterile or at least two (2) years postmenopausal, 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, monogamous relationship with same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit.
- Male subjects only: 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, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during Screening
- Have a minimum of six unrestored bicuspids and molars with less than 50% of molars and bicuspids having restorations, crowns, sealants or are missing
Key exclusion criteria (11 listed)
- Advanced periodontal disease
- Active caries lesion(s) within 30 days prior to study drug administration (confirmed by dental examination and standard radiographs).
- 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 or partial dentures, or orthodontic appliances, e.g. night guards, permanent retainers
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 RinseActive rinses are 1.6 mg/mL C16G2. | Drug | Dental Tray Gel Administration, Electric Toothbrush Gel Application, Manual Toothbrush Gel Application, Mouth Rinse Administration |
| PlaceboPlacebo is the vehicle without C16G2 | Drug | Dental Tray Gel Administration, Electric Toothbrush Gel Application, Manual Toothbrush Gel Application, Mouth Rinse Administration |
| C16G2 GelActive C16G2 Gel is 3.2 mg/mL | Drug | Dental Tray Gel Administration, Electric Toothbrush Gel Application, Manual Toothbrush Gel Application |
Primary outcome
To evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects.
Time frame: Screening, Baseline, Days 1-7, & Day 14
Safety will be assessed by comparing the incidence and duration of adverse events, clinically significant changes in vital signs, oral cavity assessments and targeted physical exams (C16G2 subjects in the four study arms vs. placebo).
2 secondary outcomes
To assess the targeted antimicrobial activity of C16G2 gel and rinse applications as measured by a reduction of dental plaque and salivary Streptococcus mutans (S. mutans).
Time frame: Screening, Baseline, Days 1, 7 & 14
To assess total bacteria in dental plaque and saliva post-study drug. administration
Time frame: Screening, Baseline, Days 1, 7 & 14
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 1 Aug 2019.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Adam Marberger, DDS principal investigator
Jean Brown Research
2 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 Rinse and C16G2 Gel in people with Dental Caries, run by Armata Pharmaceuticals, Inc. at 2 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 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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 evaluate the safety of multiple C16G2 Gel and/or C16G2 Rinse administrations in healthy adult subjects. (time frame: Screening, Baseline, Days 1-7, & Day 14). 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 1 Aug 2019.