Diabetes Type 2Phase 1DiabetesNCT00801164
Exploratory Study of Iocide Oral Rinse in a Diabetic Population
A Phase 1 study testing Frio Mouth Rinse in people with Diabetes Type 2 and Periodontitis, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Periodontitis
- What is being tested?
- Frio Mouth Rinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2010
- Phase
- Phase 1
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have self-reported type 2 diabetes of more than three months duration.
- A current HbA1c value between 7.0% and 12%.
- Report no change in diabetes-related medications during the three months prior to enrollment.
- Be at least 35 years of age.
- Have at least 16 natural teeth.
- Have moderate to severe chronic periodontitis, defined by loss of clinical attachment of >5 mm on two seperate teeth, and no treatment within six months.
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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. 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
- History, or current evidence, of any significant acute or chronic 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
- TPOab positive
- Baseline serum level of TSH <0.35 or >5.5
- Treatment with antibiotic within the three (3) month period prior to the screening examination
- Presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
- History of thyroid disease
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- Purported sensitivity or allergy to iodine
- Known sensitivity or allergy to shellfish
- History of autoimmune disease, or chronic infections such as HIV or hepatitis
- History of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
- History of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
- 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 alter the treatment needs during the 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 or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study
- History of, 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 treatment, and to return for follow-up visits as required by the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio, Dental School
San Antonio, Texas, 78229
About this study
The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.
Read the detailed description
This double-blind prospective pilot study will evaluate the effects of an investigational oral rinse as an adjunctive agent to non-surgical periodontal intervention for patients with type 2 diabetes mellitus. Approximately thirty (30) adult (35 years or older) patients with type 2 diabetes mellitus with untreated chronic periodontitis of moderate or worse severity will be enrolled in the 6-month study to provide 24 evaluable subjects (12 per group). All subjects enrolled in the trial will receive standard periodontal therapy including scaling and root planing (SRP). Half will be randomized to receive the investigational oral rinse adjunctively twice daily; the other half will receive placebo rinse twice daily. Study participants will be treated with either Iocide or placebo rinse for the first 90 days of the study only. Follow up examinations will be performed at six months. Evaluation of biological markers associated with systemic inflammation and diabetes will be performed at baseline, three months, and six months. The primary study outcome is clinical measurement of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level). Secondary outcomes are change in HbA1c and markers of systemic inflammation measured by serum C-reactive protein, plasma TNF-a, and IL-6.
- Conditions
- Diabetes Type 2, Periodontitis
- Being tested
- Frio Mouth Rinse Placebo, Frio Mouth Rinse
- Keywords
- Diabetes Type 2, Periodontitis
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frio Mouth Rinse PlaceboDrug
Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
Frio Mouth RinseDrug
Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate.
| Study group | Role | What they receive |
|---|---|---|
| Frio Oral Rinse | Experimental | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. Receives: Drug: Frio Mouth Rinse |
| Placebo | Experimental | Prescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. Receives: Drug: Frio Mouth Rinse Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score.
Measured: 6 Months
Secondary outcomes (1)
Secondary endpoints include glycated hemoglobin A1c (HbA1c) and systemic biomarkers (LPS, TNF-a, CRP, IL-6, serum insulin and glucose). Tertiary outcome measures include staining, calculus, opportunistic Candida infection, and patient satisfaction.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Methodist Healthcare Ministries of South Texas, Foundation Of Collaborative Unique Science (FOCUS)
- Responsible party
- Sponsor
- Investigators
- Thomas W. Oates, DMD, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801164
- Sponsor's protocol ID
- HSC20080508H
- Acronym
- Diabetes
- Status last verified
- Feb 2012
- First submitted
- 2 Dec 2008
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Iocide Oral Rinse in a Diabetic Population
- ClinicalTrials.gov ID
- NCT00801164
- Acronym / sponsor ID
- Diabetes / HSC20080508H
- Conditions
- Diabetes Type 2, Periodontitis
- Keywords
- Diabetes Type 2, Periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Methodist Healthcare Ministries of South Texas, Foundation Of Collaborative Unique Science (FOCUS)
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Dec 2008 (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 goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible diabetes population, and 2) evaluate its effect on glycemic control and biomarkers of systemic inflammation.
Detailed description
This double-blind prospective pilot study will evaluate the effects of an investigational oral rinse as an adjunctive agent to non-surgical periodontal intervention for patients with type 2 diabetes mellitus. Approximately thirty (30) adult (35 years or older) patients with type 2 diabetes mellitus with untreated chronic periodontitis of moderate or worse severity will be enrolled in the 6-month study to provide 24 evaluable subjects (12 per group). All subjects enrolled in the trial will receive standard periodontal therapy including scaling and root planing (SRP). Half will be randomized to receive the investigational oral rinse adjunctively twice daily; the other half will receive placebo rinse twice daily. Study participants will be treated with either Iocide or placebo rinse for the first 90 days of the study only. Follow up examinations will be performed at six months. Evaluation of biological markers associated with systemic inflammation and diabetes will be performed at baseline, three months, and six months. The primary study outcome is clinical measurement of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level). Secondary outcomes are change in HbA1c and markers of systemic inflammation measured by serum C-reactive protein, plasma TNF-a, and IL-6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frio Oral Rinse | Experimental | Drug: Frio Mouth RinsePrescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
| Placebo | Experimental | Drug: Frio Mouth Rinse PlaceboPrescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have self-reported type 2 diabetes of more than three months duration.
- A current HbA1c value between 7.0% and 12%.
- Report no change in diabetes-related medications during the three months prior to enrollment.
- Be at least 35 years of age.
- Have at least 16 natural teeth.
Key exclusion criteria (22 listed)
- History, or current evidence, of any significant acute or chronic 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
- TPOab positive
- Baseline serum level of TSH <0.35 or >5.5
- Treatment with antibiotic within the three (3) month period prior to the screening examination
- Presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
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 |
|---|---|---|
| Frio Mouth Rinse PlaceboPrescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. | Drug | Placebo |
| Frio Mouth RinsePrescription Mouth Rinse. Rinse with 15ml twice daily then expectorate. | Drug | Frio Oral Rinse |
Primary outcome
The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score.
Time frame: 6 Months
1 secondary outcome
Secondary endpoints include glycated hemoglobin A1c (HbA1c) and systemic biomarkers (LPS, TNF-a, CRP, IL-6, serum insulin and glucose). Tertiary outcome measures include staining, calculus, opportunistic Candida infection, and patient satisfaction.
Time frame: 6 Months
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 2 Feb 2012.
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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.
Thomas W. Oates, DMD, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Frio Mouth Rinse in people with Diabetes Type 2 and Periodontitis, 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 22 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 2 Feb 2012. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary study endpoints are periodontal evaluation including clinical attachment level, pocket depth, plaque index, suppuration and gingival index score. (time frame: 6 Months). 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 2 Feb 2012.