Gingival DiseasesPhase 2NCT00391547
Pilot Efficacy Study to Treat Gingivitis
A Phase 2 study testing Frio Oral Rinse in people with Gingival Diseases, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Frio Oral Rinse
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2007
- 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 18 years of age, and in good general health, as determined by Investigator.
- Have 16 natural, gradable teeth and good dental health, as determined by Investigator.
- Have > 25% sites with GI scores > 2.
- Have average 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 (drug) 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
- Subjects meeting any of the following exclusion criteria are not eligible for participation in this study:
- 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.
- Treatment with antibiotic within the one (1) month period prior to the screening examination.
- Presence of heart murmur, history of rheumatic fever, valvular disease or prosthetic implant requiring antibiotic premedication.
- History of thyroid disease.
- Known sensitivity or allergy to iodine.
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- 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.
- 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.
- 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 (4) 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.
- Unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment (drug), 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 Missouri at Kansas City, School of Dentistry
Kansas City, Missouri, 64108
About this study
Official title: Phase II Pilot Efficacy Study to Treat Gingivitis
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.
Read the detailed description
Gingivitis is an endemic disease that is a precursor to periodontal disease. Two mouthrinse agents, Peridex and Listerine, have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association for the control of supragingival plaque and gingivitis. Peridex (0.12% chlorhexidine, bisbiguanide cationic detergent) is a prescription mouthrinse that demonstrates potent anti-plaque and anti-gingivitis action. Chlorhexidine rinses are also prescribed to prevent post surgical infections. Chlorhexidine has broad spectrum antibacterial activity and substantivity. With prolonged use, chlorhexidine maintains its effectiveness but causes staining of natural teeth and composite materials used in restorative dentistry. Other side effects associated with chlorhexidine are calculus formation and possible alterations in taste. Although chlorhexidine rinses and supragingival irrigations have demonstrated significant efficacy in reducing plaque and gingivitis, chlorhexidine has had a minimal impact in treating periodontal disease. Listerine, comprised of essential oils, is an over-the-counter mouthrinse that is less effective than chlorhexidine in controlling plaque and gingivitis, but has minimal side effects. Other agents such as quaternary ammonium compounds and metal salts are rarely used alone but can be used in combination with other antimicrobial rinses to enhance their effectiveness.
- Conditions
- Gingival Diseases
- Being tested
- Frio Oral Rinse
- Keywords
- Gingivitis Disease
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frio Oral RinseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the Gingival Index values over a 12 weeks period.
Secondary outcomes (1)
Reduction of the Plaque Index values over a 12 weeks period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startOct 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseasesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Lynn Friesen, DDS, Principal investigator, University of Missouri at Kansas City, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391547
- Sponsor's protocol ID
- 0609059R44NR009015-02
- Other IDs
- NIH Grant No. 9R44NR009015-02
- Status last verified
- Oct 2007
- First submitted
- 20 Oct 2006
- Last updated
- 22 Oct 2007
- Results posted
- No
Publications
Guidance for Industry Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Efficacy Study to Treat Gingivitis
- ClinicalTrials.gov ID
- NCT00391547
- Acronym / sponsor ID
- 0609059R44NR009015-02
- Conditions
- Gingival Diseases
- Keywords
- Gingivitis Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2006
- Study completion
- Jan 2007
- First posted
- 24 Oct 2006 (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 primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.
Detailed description
Gingivitis is an endemic disease that is a precursor to periodontal disease. Two mouthrinse agents, Peridex and Listerine, have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association for the control of supragingival plaque and gingivitis. Peridex (0.12% chlorhexidine, bisbiguanide cationic detergent) is a prescription mouthrinse that demonstrates potent anti-plaque and anti-gingivitis action. Chlorhexidine rinses are also prescribed to prevent post surgical infections. Chlorhexidine has broad spectrum antibacterial activity and substantivity. With prolonged use, chlorhexidine maintains its effectiveness but causes staining of natural teeth and composite materials used in restorative dentistry. Other side effects associated with chlorhexidine are calculus formation and possible alterations in taste. Although chlorhexidine rinses and supragingival irrigations have demonstrated significant efficacy in reducing plaque and gingivitis, chlorhexidine has had a minimal impact in treating periodontal disease. Listerine, comprised of essential oils, is an over-the-counter mouthrinse that is less effective than chlorhexidine in controlling plaque and gingivitis, but has minimal side effects. Other agents such as quaternary ammonium compounds and metal salts are rarely used alone but can be used in combination with other antimicrobial rinses to enhance their effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:
- Males or non-pregnant females of 18 years of age, and in good general health, as determined by Investigator.
- Have 16 natural, gradable teeth and good dental health, as determined by Investigator.
- Have > 25% sites with GI scores > 2.
- Have average PI score > 2.
Key exclusion criteria (20 listed)
- Subjects meeting any of the following exclusion criteria are not eligible for participation in this study:
- 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.
- Treatment with antibiotic within the one (1) month period prior to the screening examination.
- Presence of heart murmur, history of rheumatic fever, valvular disease or prosthetic implant requiring antibiotic premedication.
- History of thyroid disease.
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 Oral Rinse | Drug | – |
Primary outcome
Reduction of the Gingival Index values over a 12 weeks period.
1 secondary outcome
Reduction of the Plaque Index values over a 12 weeks period.
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 22 Oct 2007.
- BackgroundGuidance for Industry Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention
Related trials for Gingival Diseases
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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.
Lynn Friesen, DDS principal investigator
University of Missouri at Kansas City, School of Dentistry
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 Frio Oral Rinse in people with Gingival Diseases, 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 20 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 Oct 2007. 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 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?
Reduction of the Gingival Index values over a 12 weeks period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391547, which also lists 1 linked publication.
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 Oct 2007.