GingivitisPhase 2NCT01103102
Dose-Response Study of Iocide Oral Rinse
A Phase 2 study testing Iocide Oral Rinse in people with Gingivitis, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
The purpose of this study is to explore the dose-response relationship of Iocide oral rinse in a clinical trial of gingivitis. Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into the 3-month study to provide 40 total evaluable subjects (10 per group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- 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
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2012
- 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
- 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 > 2;
- Have average Plaque Index (PI) score > 2;
- Use of effective method of contraception for the duration of the study or permanently sterilized;
- 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), levonogestrel implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.
Who cannot join
- 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;
- TPOab positive >34;
- Screening serum level of TSH <0.45 or >4.5;
- Treatment with antibiotic within the one (1) month period prior to the screening examination;
- History of heart murmur, history of rheumatic fever, valvular disease or prosthetic implant requiring antibiotic premedication;
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- 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;
- Periodontal disease screening will be performed by assessing periodontal pocket depths >5mm on six (6) sites per tooth (distofacial, facial, mesiofacial, mesiolingual, lingual and distolingual). A UNC-15 periodontal probe (Hu-Friedy) will be used for all measurements. Any subject with true periodontal pockets > 5 mm will be excluded from participation in this study;
- 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;
- Use of concomitant medication that, in the opinion of the Investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin);
- 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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Phase II Study: Evaluate Dose-Response of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects of Biological Markers Indicative of Systemic Disease
The purpose of this study is to explore the dose-response relationship of Iocide oral rinse in a clinical trial of gingivitis.
Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into the 3-month study to provide 40 total evaluable subjects (10 per group). Each study participant will have four visits: a screening visit up to 21 days before the beginning of the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the dose/range study will be three months to facilitate compliance and ensure timely completion of the Phase II study.
Three dose/regimens will be evaluated against a placebo control oral 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.
- Conditions
- Gingivitis
- Being tested
- Iocide Oral Rinse, Placebo
- Keywords
- Gingivitis, Biological Markers
- 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
Oral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lowest Dose | Active comparator | Not described Receives: Drug: Iocide Oral Rinse |
| Intermediate Dose | Active comparator | Not described Receives: Drug: Iocide Oral Rinse |
| Highest Dose | Active comparator | Not described Receives: Drug: Iocide Oral Rinse |
| Placebo Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
The primary outcome measure will be the mean gingival index (GI) score.
Measured: Study Day -21 to -7 through Study Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionApr 2012
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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas
- Responsible party
- Sponsor
- Investigators
- David L. Cochran, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103102
- Sponsor's protocol ID
- HSC20090462H
- Other IDs
- 1R44HL101821-01
- Status last verified
- Jan 2013
- First submitted
- 12 Apr 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Evaluate Dose-Response of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects of Biological Markers Indicative of Systemic Disease
- ClinicalTrials.gov ID
- NCT01103102
- Acronym / sponsor ID
- HSC20090462H
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Biological Markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Apr 2010 (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 dose-response relationship of Iocide oral rinse in a clinical trial of gingivitis.
Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into the 3-month study to provide 40 total evaluable subjects (10 per group). Each study participant will have four visits: a screening visit up to 21 days before the beginning of the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the dose/range study will be three months to facilitate compliance and ensure timely completion of the Phase II study.
Three dose/regimens will be evaluated against a placebo control oral 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Lowest Dose | Active comparator | Drug: Iocide Oral Rinse |
| Intermediate Dose | Active comparator | Drug: Iocide Oral Rinse |
| Highest Dose | Active comparator | Drug: Iocide Oral Rinse |
| Placebo Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 > 2;
- Have average Plaque Index (PI) score > 2;
- Use of effective method of contraception for the duration of the study or permanently sterilized;
Key exclusion criteria (24 listed)
- 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;
- TPOab positive >34;
- Screening serum level of TSH <0.45 or >4.5;
- Treatment with antibiotic within the one (1) month period prior to the screening examination;
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 RinseOral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration | Drug | Highest Dose, Intermediate Dose, Lowest Dose |
| PlaceboPlacebo | Drug | Placebo Control |
Primary outcome
Gingival Index
Time frame: Study Day -21 to -7 through Study Day 84
The primary outcome measure will be the mean gingival index (GI) score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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.
David L. Cochran, DDS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
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, 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 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 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?
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?
Gingival Index (time frame: Study Day -21 to -7 through Study Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.