Gingival DiseasesPhase 3NCT00759187
Evaluate Clinical Research From Commerical Oral Care Products
A Phase 3 study testing Fluoride, Triclosan/Fluoride and Chlorhexidine Gluconate in people with Gingival Diseases, run by Colgate Palmolive at 1 site in United States.
Trial summary
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Fluoride, Triclosan/Fluoride and Chlorhexidine Gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Who cannot join
- Subjects unable or unwilling to sign the informed consent form.
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
- 2 or more decayed untreated dental sites at screening.
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
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- Use of medications that can currently affect salivary flow.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Pregnant or nursing women.
- Participation in any other clinical study within 1 week prior to enrollment into this study.
- Allergy to chlorhexidine
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates.
- Current use of Antibiotics for any purpose.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Dental Medicine
Boston, Massachusetts, 02118
About this study
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Read the detailed description
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
- Conditions
- Gingival Diseases
- Being tested
- Fluoride, Triclosan/Fluoride, Chlorhexidine Gluconate
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Also called monofluorophosphate
Brush twice daily
Triclosan/FluorideDrug
Also called sodium fluoride, triclosan
Half mouth toothbrushing twice daily for 4 days
Chlorhexidine GluconateDrug
Also called Chlorhexidine Gluconate oral rinse
Mouth rinsing twice a day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Fluoride |
| B | Active comparator | Not described Receives: Drug: Triclosan/Fluoride |
| C | Active comparator | Not described Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Plaque Index
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
Measured: 4-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Van Dyke, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759187
- Sponsor's protocol ID
- CRO-0607-PLA-11-RR
- Status last verified
- Nov 2008
- First submitted
- 23 Sep 2008
- Last updated
- 4 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Clinical Research From Commerical Oral Care Products
- ClinicalTrials.gov ID
- NCT00759187
- Acronym / sponsor ID
- CRO-0607-PLA-11-RR
- Conditions
- Gingival Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 18 Nov 2008
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 conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Detailed description
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Fluoride |
| B | Active comparator | Drug: Triclosan/Fluoride |
| C | Active comparator | Drug: Chlorhexidine Gluconate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Key exclusion criteria (17 listed)
- Subjects unable or unwilling to sign the informed consent form.
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
- 2 or more decayed untreated dental sites at screening.
- Other disease of the hard or soft oral tissues.
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 |
|---|---|---|
| FluorideAlso: monofluorophosphateBrush twice daily | Drug | A |
| Triclosan/FluorideAlso: sodium fluoride, triclosanHalf mouth toothbrushing twice daily for 4 days | Drug | B |
| Chlorhexidine GluconateAlso: Chlorhexidine Gluconate oral rinseMouth rinsing twice a day for 4 days | Drug | C |
Primary outcome
Dental Plaque Index
Time frame: 4-Day
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Van Dyke, DDS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride, Triclosan/Fluoride and Chlorhexidine Gluconate in people with Gingival Diseases, run by Colgate Palmolive 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 5 inclusion and 17 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 4 Mar 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dental Plaque Index (time frame: 4-Day). 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 4 Mar 2010.