Dental PlaquePhase 3QuigleyNCT01021007

Clinical Research Study Efficacy of a Prototype Oral Rinse

A Phase 3 study testing Iodine and water in people with Dental Plaque, run by Colgate Palmolive at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dental Plaque
What is being tested?: Iodine and water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Nov 2007
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 16 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.
Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

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
History of allergy to iodine
History of thyroid disease
History of diabetes

Show all 21Show fewer

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).
Use of medications that are 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.
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)
Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
Smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

New Institutional Service Company
Northfield, New Jersey, 08225

Other trials in United States

About this study

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Conditions: Dental Plaque
Being tested: Iodine, water
Medical subject headings: Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IodineDrug
Also called Iocide (proprietary company name)
Rinse 2 times per day for 6 weeks
waterOther
Also called No actives present in control mouthrinse. (Flavored water)
Use 2 times per day for 6 weeks

Study groups in NCT01021007
Study group	Role	What they receive
A	Placebo comparator	control mouthrinse Receives: Other: water
B	Experimental	new prototype mouthrinse Receives: Drug: Iodine

What is being measured

The primary outcome is the main question the study is designed to answer.

Gingival Index
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding
Measured: 6 weeks
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale
0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.
Measured: 6 weeks
Plaque Index (Quigley-Hein Score)
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Nov 2007

First posted26 Nov 2009 (estimated)
Study startOct 2007
Primary completionNov 2007
Study completionNov 2007

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 Dental PlaqueStudies 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: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01021007
Sponsor's protocol ID: CRO-1007-GIN-02-RR
Acronym: Quigley
Status last verified: Oct 2009
First submitted: 26 Sep 2008
Last updated: 1 Dec 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
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Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
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Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis

All Dental Plaque trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Research Study Efficacy of a Prototype Oral Rinse
ClinicalTrials.gov ID: NCT01021007
Acronym / sponsor ID: Quigley / CRO-1007-GIN-02-RR
Conditions: Dental Plaque
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 26 Nov 2009 (estimated)
Results: Posted 26 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Placebo comparator	Other: watercontrol mouthrinse
B	Experimental	Drug: Iodinenew prototype mouthrinse

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female volunteers 18-65 years of age
Good general health
Must sign informed consent form
Minimum of 16 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 (21 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
History of allergy to iodine
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
IodineAlso: Iocide (proprietary company name)Rinse 2 times per day for 6 weeks	Drug	B
waterAlso: No actives present in control mouthrinse. (Flavored water)Use 2 times per day for 6 weeks	Other	A

Primary outcome

Gingival Index
Time frame: 6 weeks
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale
Time frame: 6 weeks
0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.
Plaque Index (Quigley-Hein Score)
Time frame: 6 weeks
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Results and safety

Results posted to the registry on 26 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Negative Control Rinse	36	34
Iocide Mouthrinse	37	33

Primary outcome: Gingival Index

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Negative Control Rinse n = 34	Iocide Mouthrinse n = 33
Value	1.90 (0.19)	1.84 (0.23)

Negative Control Rinse vs Iocide Mouthrinse: p = 0.005, ANCOVA

Primary outcome: EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale

Time frame: 6 weeks. Mean (Standard Deviation). Unit: bleeding sites

Measure	Negative Control Rinse n = 34	Iocide Mouthrinse n = 33
Value	40.82 (16.93)	34.91 (23.83)

Negative Control Rinse vs Iocide Mouthrinse: p = 0.05, ANCOVA

Primary outcome: Plaque Index (Quigley-Hein Score)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Negative Control Rinse n = 34	Iocide Mouthrinse n = 33
Value	2.47 (0.61)	2.11 (0.70)

Negative Control Rinse vs Iocide Mouthrinse: p = 0.05, ANCOVA

Adverse events

Time frame: 7 week study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Negative Control Rinse	0 of 34 (0%)	12 of 34 (35.3%)	Not reported
Iocide Mouthrinse	0 of 33 (0%)	9 of 33 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Plaque

Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis

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.

Matthew Cronin, DMD 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 Iodine and water in people with Dental Plaque, 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 6 inclusion and 21 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 1 Dec 2009. 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 26 Nov 2009). 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?

Gingival Index (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT01021007.

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 1 Dec 2009.