Oral Malodor
Conditions
Brief summary
The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in human subjects in controlling oral malodor in partial fulfillment of the requirements for American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.
Detailed description
Study Design: The products used in the study are: ClōSYS Alcohol-Free Oral Rinse (also referred as ClōSYS Unflavored Oral Rinse) and ClōSYS justRIGHT MILD MINT Oral Rinse (also referred as ClōSYS Flavored Oral Rinse or Gentle Mint Flavored Oral Rinse). This is an in-vivo, eight-week, a single-center, randomized, double-blind (subject/investigator), 2-way cross-over design clinical study. There are two independent groups. Each subject of each group gets crossed over to the other sub-group within a same group after the washout period. Each group has their own control group. In the first phase, 25 subjects (50%) of each group are randomly assigned to the active group; the other 25 subjects are assigned to the control group. In the second phase, the participants will be crossed over within sub-group assignment. The Study enrolled 100 subjects, aged 21 to 65 years, with a slight to strong intrinsic oral malodor, as determined by a panel of trained odor judges calibrated and standardized using a range of standard odorants sufficient to reflect the different patterns of nose receptors. Study Plan: Subjects will receive verbal and written oral hygiene instructions, and either one bottle (16 oz. each) of ClōSYS Unflavored Oral Rinse, ClōSYS Flavored Oral Rinse- or Placebo Oral Rinse each week. Subjects will also receive measuring cups for dispensing the rinse and a diary log for recording usage (the Oral Hygiene Kit) for use during the treatment. After a 2-week wash out period, each subject will receive another bottle of oral rinse according to their group assignment. Subjects will be instructed to rinse twice a day, each in the morning and in the evening, with 15 mL mouth rinse for 30 seconds. They will note in their patient's log the date and time of rinsing. Subjects will be instructed to continue with their normal oral hygiene practices, including tooth brushing but omitting any use of oral rinses or mouthwashes except for the Study materials. The subjects also will be instructed not to use other non-study related products such as breath mints, lozenge, gums, etc. as well as refraining from elective dental procedures during the study period.
Interventions
Subjects in Test group will receive ClōSYS® Unflavored Rinse.
Subjects in Test group will receive ClōSYS® Flavored Rinse.
OTHERPlacebo
Subjects in Placebo group will receive Placebo Rinse.
Sponsors
Loma Linda University
Rowpar Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Completion of the Informed Consent. * Must be able to follow verbal/written instructions. * Between 21 to 65 years of age, male or female. * Has normal oral interior cheek wall tissues. * In good general health. * Should not have any severe or debilitating disease that may impede participation. * Average organoleptic intensity rating of at \>2.6 but \<4.5 on an intensity scale of 0-5.
Exclusion criteria
* Pregnant or nursing. * Diagnosis of Xerostomia, including medication induced Xerostomia. * Oral or extraoral piercing that interferes with the clinical assessments in the mouth. * Fixed or removable oral appliance. * Advanced periodontal disease or excessive gingival recession. * Known allergy or sensitivity to study products. * Unwilling to abstain from all oral hygiene products other than those prescribed for the study. * Heavy deposits of calculus, either supragingival and/or subgingival. * History of severe transmittable infectious disease e.g. hepatitis, HIV, tuberculosis. * Medical or dental condition that would be unduly affected by participation in this study. * Any other condition that may interfere with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Malodor as Measured by Organoleptic Score | At baseline and weekly for 3 weeks for each condition and cross-over | A 6-level organoleptic score from 0 - 5 will be used. Score of 0 indicating malodor cannot be detected and score of 5 indicating very strong malodor. Breath scores were compared to baseline with malodor intensity reduction recorded as negative. |
Participant flow
Recruitment details
Study panelists were recruited by placing IRB-approved advertisements in the the Loma Linda University newsletter and local communities. Potential subjects were interviewed by telephone and screened for their eligibility to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Test-Unflavored Rinse, Then Placebo Participants received ClōSYS® Unflavored Rinse, Then Placebo Unflavored Rinse | 25 |
| Test-Flavored Rinse, Then Placebo Subjects received ClōSYS® Flavored Rinse, Then Placebo Flavored Rinse. | 25 |
| Placebo, Then Flavored Rinse Subjects in Placebo group received Placebo Rinse, then ClōSYS® Flavored Rinse | 25 |
| Placebo, Then Unflavored Rinse Subjects in Placebo group received Placebo Rinse, then ClōSYS® Unflavored Rinse. | 25 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Intervention (3 Weeks) | Withdrawal by Subject | 2 | 1 | 1 | 0 |
| Second Intervention (3 Weeks) | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Test-Flavored Rinse, Then Placebo | Placebo, Then Flavored Rinse | Placebo, Then Unflavored Rinse | Test-Unflavored Rinse, Then Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 25 Participants | 25 Participants | 100 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 13.3 | 38.2 years STANDARD_DEVIATION 13.3 | 45.7 years STANDARD_DEVIATION 13.9 | 45.6 years STANDARD_DEVIATION 13.5 | 42.5 years STANDARD_DEVIATION 13.5 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 25 participants | 25 participants | 100 participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 8 Participants | 10 Participants | 52 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 17 Participants | 13 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change in Malodor as Measured by Organoleptic Score
A 6-level organoleptic score from 0 - 5 will be used. Score of 0 indicating malodor cannot be detected and score of 5 indicating very strong malodor. Breath scores were compared to baseline with malodor intensity reduction recorded as negative.
Time frame: At baseline and weekly for 3 weeks for each condition and cross-over
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 3 | 2.58 score on a scale | Standard Deviation 0.43 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Baseline | 3.09 score on a scale | Standard Deviation 0.34 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 1 | 2.90 score on a scale | Standard Deviation 0.52 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 2 | 2.64 score on a scale | Standard Deviation 0.48 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Baseline 2-Crossover | 3.44 score on a scale | Standard Deviation 0.5 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 6 | 3.18 score on a scale | Standard Deviation 0.61 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 7 | 3.01 score on a scale | Standard Deviation 0.59 |
| Unflavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 8 | 2.96 score on a scale | Standard Deviation 0.49 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 6 | 3.04 score on a scale | Standard Deviation 0.49 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Baseline 2-Crossover | 3.20 score on a scale | Standard Deviation 0.44 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 1 | 2.92 score on a scale | Standard Deviation 0.31 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 8 | 2.83 score on a scale | Standard Deviation 0.44 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Baseline | 3.08 score on a scale | Standard Deviation 0.38 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 3 | 2.68 score on a scale | Standard Deviation 0.51 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 2 | 2.78 score on a scale | Standard Deviation 0.4 |
| Flavored Rinse, Then Placebo | Change in Malodor as Measured by Organoleptic Score | Week 7 | 2.94 score on a scale | Standard Deviation 0.48 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 1 | 3.11 score on a scale | Standard Deviation 0.46 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 2 | 3.07 score on a scale | Standard Deviation 0.53 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 3 | 3.07 score on a scale | Standard Deviation 0.44 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Baseline 2-Crossover | 3.15 score on a scale | Standard Deviation 0.42 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 6 | 3.17 score on a scale | Standard Deviation 0.46 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 8 | 3.10 score on a scale | Standard Deviation 0.4 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Baseline | 3.03 score on a scale | Standard Deviation 0.19 |
| Placebo Flavored, Then Flavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 7 | 3.13 score on a scale | Standard Deviation 0.4 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 1 | 3.19 score on a scale | Standard Deviation 0.5 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 3 | 3.19 score on a scale | Standard Deviation 0.43 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 2 | 3.12 score on a scale | Standard Deviation 0.43 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 7 | 3.10 score on a scale | Standard Deviation 0.5 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Baseline 2-Crossover | 3.14 score on a scale | Standard Deviation 0.46 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 8 | 3.09 score on a scale | Standard Deviation 0.43 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Baseline | 3.23 score on a scale | Standard Deviation 0.41 |
| Placebo Unflavored, Then Unflavored Rinse | Change in Malodor as Measured by Organoleptic Score | Week 6 | 3.0 score on a scale | Standard Deviation 0.41 |
Comparison: Baseline, Week 1, Week 2, Week 3p-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Baseline, Week 1, Week 2, Week 3p-value: 0.932Wilcoxon (Mann-Whitney)
Comparison: Baseline 2, Week 6, Week 7, Week 8p-value: 0.853Wilcoxon (Mann-Whitney)
Comparison: Baseline-2, Week 6, Week 7, Week 8p-value: 0.032Wilcoxon (Mann-Whitney)
Comparison: Baseline, Week 1, Week 2, Week 3p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Baseline, Week 1, Week 2, Week 3p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Baseline 2, Week 6, Week 7, Week 8p-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: Baseline 2, Week 6, Week 7, Week 8p-value: 0.006Wilcoxon (Mann-Whitney)