GingivitisPhase 2NCT01782170
Efficacy of Iocide Oral Rinse Against Gingival Inflammation
A Phase 2 study testing Iocide Oral Rinse in people with Gingivitis and Investigation of Biological Markers of Inflammation, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Investigation of Biological Markers of Inflammation
- What is being tested?
- Iocide Oral Rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:
- Males or non-pregnant females of at least 18 years of age, and in good general health, as determined by Investigator;
- Have at least 16 natural, gradable teeth and good dental health, as determined by Investigator;
- Have > 25% sites with Gingival Index (GI) scores of > 2 at Visits 1 and 2;
- Have Plaque Index (PI) scores of > 1 on > 50% of sites;
- Use of effective method of contraception for the duration of the study or permanently sterilized;
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- Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol;
- Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures;
- Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control or abstinence. These methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.
Who cannot join
- Subjects meeting any of the following exclusion criteria will not be eligible for participation in this study:
- History, or current evidence, of any significant acute or chronic subject-reported medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation;
- ≤24% of sites with GI score >2;
- Thyroid peroxidase antibody (TPOab) positive >34;
- Screening serum level of thyroid stimulating hormone (TSH) <0.45 or >4.5;
- Treatment with antibiotic within the one (1) month period prior to the screening examination;
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- History of heart murmur, history of rheumatic fever, valvular disease, prosthetic implant or any other condition requiring antibiotic premedication;
- History of thyroid disease;
- Purported sensitivity or allergy to iodine;
- Known sensitivity or allergy to shellfish;
- History of diabetes;
- History of autoimmune disease;
- Gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the Investigator, could influence the outcome of the study;
- True periodontal pockets of > 5 mm and/or visible recession indicative of attachment loss;
- Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores;
- Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed;
- History of early onset periodontal disease or acute necrotizing ulcerative gingivitis;
- Subject reported history in past 6 months or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study;
- Subject reported history of last past 6 months or current drug abuse;
- Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, non-steroidal antiinflammatory drugs, and aspirin) within 1 month of the screening examination. All other medications for chronic medical conditions have been initiated at least 3 months before enrollment;
- Current use of a statin or the use of a statin within the past sixty (60) days of screening;
- Concomitant therapy with another investigational drug or device without prior approval from the Sponsor within four weeks prior to Visit 2 (Study Day 1);
- Concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months;
- Females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study;
- Residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues);
- Unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study intervention, and to return for follow-up visits as required by the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky, Center for Oral Health Research, College of Dentistry
Lexington, Kentucky, 40506
Dolph Dawson, DMD, MS
About this study
Official title: Phase II Study: Evaluate Efficacy of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects on Biological Markers Indicative of Systemic Disease
The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral rinse on relative levels of biological markers of inflammation.
- Being tested
- Iocide Oral Rinse, Placebo
- Keywords
- Gingivitis, Biomarkers, Biological Markers of Inflammation
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iocide Oral RinseDrug
Also called Iocide Oral Rinse - once daily 30 second rinse for 24 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Iocide Oral Rinse | Active comparator | Iocide Oral Rinse once daily 30 second rinse for 24 weeks Receives: Drug: Iocide Oral Rinse |
| Placebo Control | Placebo comparator | Once daily 30 second rinse for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Gingival Index (GI)
Measured: Study Days -21 to -7 through Study Day 168
Secondary outcomes (1)
Change in Biological Marker Data
Measured: Study Day 1, Day 28, Day 84 and Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
- Study completionMay 2014 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Kentucky
- Responsible party
- Sponsor
- Investigators
- Dolphus R Dawson III, DMD, MS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782170
- Sponsor's protocol ID
- UK12-0972-F2L
- Other IDs
- R44HL101821
- Status last verified
- Aug 2013
- First submitted
- 29 Jan 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Evaluate Efficacy of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects on Biological Markers Indicative of Systemic Disease
- ClinicalTrials.gov ID
- NCT01782170
- Acronym / sponsor ID
- UK12-0972-F2L
- Keywords
- Gingivitis, Biomarkers, Biological Markers of Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Kentucky
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 1 Feb 2013 (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 explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral rinse on relative levels of biological markers of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iocide Oral Rinse | Active comparator | Drug: Iocide Oral RinseIocide Oral Rinse once daily 30 second rinse for 24 weeks |
| Placebo Control | Placebo comparator | Drug: PlaceboOnce daily 30 second rinse for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:
- Males or non-pregnant females of at least 18 years of age, and in good general health, as determined by Investigator;
- Have at least 16 natural, gradable teeth and good dental health, as determined by Investigator;
- Have > 25% sites with Gingival Index (GI) scores of > 2 at Visits 1 and 2;
- Have Plaque Index (PI) scores of > 1 on > 50% of sites;
Key exclusion criteria (26 listed)
- Subjects meeting any of the following exclusion criteria will not be eligible for participation in this study:
- History, or current evidence, of any significant acute or chronic subject-reported medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation;
- ≤24% of sites with GI score >2;
- Thyroid peroxidase antibody (TPOab) positive >34;
- Screening serum level of thyroid stimulating hormone (TSH) <0.45 or >4.5;
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 |
|---|---|---|
| Iocide Oral RinseAlso: Iocide Oral Rinse - once daily 30 second rinse for 24 weeks | Drug | Iocide Oral Rinse |
| Placebo | Drug | Placebo Control |
Primary outcome
Change in Mean Gingival Index (GI)
Time frame: Study Days -21 to -7 through Study Day 168
1 secondary outcome
Change in Biological Marker Data
Time frame: Study Day 1, Day 28, Day 84 and Day 168
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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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.
Dolphus R Dawson III, DMD, MS principal investigator
University of Kentucky
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 Iocide Oral Rinse in people with Gingivitis and Investigation of Biological Markers of Inflammation, run by Biomedical Development Corporation 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 9 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 14 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailey Gallivan, CCRP (859-323-4923, hbwils00@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Gingival Index (GI) (time frame: Study Days -21 to -7 through Study Day 168). 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 14 Aug 2013.