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CompletedNCT01021007QuigleyUpdated Dec 1, 2009Results posted

Clinical Research Study Efficacy of a Prototype Oral Rinse

A Phase 3 interventional study of Iodine and water in Dental Plaque, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-01.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dental Plaque

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03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's enrollment of 67 is above the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female volunteers 18-65 years of age
  2. Good general health
  3. Must sign informed consent form
  4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
  5. 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.
  6. 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

Exclusion criteria

Exclusion Criteria:

  1. Subjects unable or unwilling to sign the informed consent form.
  2. Medical condition which requires pre-medication prior to dental visits/procedures
  3. Moderate or advanced periodontal disease
  4. History of allergy to iodine
  5. History of thyroid disease
  6. History of diabetes
  7. 2 or more decayed untreated dental sites at screening.
  8. Other disease of the hard or soft oral tissues.
  9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  10. Use of medications that are currently affect salivary flow.
  11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  12. Pregnant or nursing women.
  13. Participation in any other clinical study within 1 week prior to enrollment into this study.
  14. Use of tobacco products
  15. Subjects who must receive dental treatment during the study dates.
  16. Current use of Antibiotics for any purpose.
  17. Presence of an orthodontic appliance.
  18. History of allergy to common dentifrice ingredients
  19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
  21. Smoker
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Placebo comparator
    A

    control mouthrinse

    Other: water

  • Experimental
    B

    new prototype mouthrinse

    Drug: Iodine

Interventions

  • DrugIodine

    Rinse 2 times per day for 6 weeks

    Also known as: Iocide (proprietary company name)

  • Otherwater

    Use 2 times per day for 6 weeks

    Also known as: No actives present in control mouthrinse. (Flavored water)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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)

    Time frame: 6 weeks

07

Results

Posted Nov 26, 2009

Participant flow

At clinical site

Participant flow — Overall Study
MilestoneNegative Control RinseIocide Mouthrinse
Started3637
Completed3433
Not completed24
Withdrew: Lost to follow-up11
Withdrew: Adverse event13

Outcome measures

PrimaryGingival 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

Time frame:
6 weeks
Reported as:
Mean · Units on a scale
Gingival Index
Units on a scaleNegative Control RinseIocide Mouthrinse
Gingival Index1.90 ± 0.191.84 ± 0.23
Statistical analysis
  • Negative Control Rinse vs Iocide Mouthrinse · ANCOVA · p = 0.005ANCOVA method using treatment as the factor and the baseline score as a covariate
PrimaryEIBI 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.

Time frame:
6 weeks
Reported as:
Mean · bleeding sites
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale
bleeding sitesNegative Control RinseIocide Mouthrinse
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale40.82 ± 16.9334.91 ± 23.83
Statistical analysis
  • Negative Control Rinse vs Iocide Mouthrinse · ANCOVA · p = 0.05ANCOVA method using treatment as the factor and the baseline score as a covariate
PrimaryPlaque 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)

Time frame:
6 weeks
Reported as:
Mean · Units on a scale
Plaque Index (Quigley-Hein Score)
Units on a scaleNegative Control RinseIocide Mouthrinse
Plaque Index (Quigley-Hein Score)2.47 ± 0.612.11 ± 0.70
Statistical analysis
  • Negative Control Rinse vs Iocide Mouthrinse · ANCOVA · p = 0.05ANCOVA method using treatment as the factor and the baseline score as a covariate

Adverse events

Collected over 7 week study period. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Negative Control Rinse—0/34 (0%)12/34 (35.3%)
Iocide Mouthrinse—0/33 (0%)9/33 (27.3%)
Most frequent other events
Most frequent other events
EventNegative Control RinseIocide Mouthrinse
discomfort in mouth or bodySocial circumstances8/340/33
Tooth stainingGeneral disorders1/347/33
slight swelling or inflammation of the gumsGeneral disorders3/342/33

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Negative Control RinseIocide MouthrinseTotal
<=18 years000
Between 18 and 65 years363773
>=65 years000
Age Continuous
Age Continuous(years)Negative Control RinseIocide MouthrinseTotal
Mean37.8 ± 8.336.6 ± 10.937.2 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Negative Control RinseIocide MouthrinseTotal
Female292453
Male71320
Region of Enrollment
Region of Enrollment(participants)Negative Control RinseIocide MouthrinseTotal
United States363773
08

Study locations

1 site
  • New Institutional Service Company
    Northfield, New Jersey 08225, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01021007
Lead sponsor
Colgate Palmolive
First posted
Nov 26, 2009
Start date
Oct 2007
Primary completion
Nov 2007
Completion
Nov 2007
Results posted
Nov 26, 2009
Last update
Dec 1, 2009

Study contacts

Matthew Cronin, DMD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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