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| Name | Class |
|---|---|
| CONFADENT Oral Technology, Kiss Industries LLC | UNKNOWN |
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This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPC + Xylitol chewing gum, then Xylitol only chewing gum | Experimental | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days. |
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| Xylitol only chewing gum, then CPC + Xylitol chewing gum | Experimental | Xylitol only chewing gum and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum | Drug | All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index | Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
| day 1 |
| Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index | Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
| day 22 |
| Degree of Gingivitis as Assessed by the Gingival Index (GI) | Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
|
| Measure | Description | Time Frame |
|---|---|---|
| Discoloration of Teeth as Assessed by the Vita Scale | Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavia Lakschevitz, DDS, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
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1 participant was enrolled but then was lost to follow up before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPC + Xylitol Chewing Gum, Then Xylitol Only Chewing Gum | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum, and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days. |
| FG001 | Xylitol Only Chewing Gum, Then CPC + Xylitol Chewing Gum | Xylitol only chewing gum, and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used during one period of 21 days and Xylitol only chewing gum will be used during another period of 21 days, with the two periods divided by a washout period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index | Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 1 |
|
Through the day 22 visit of second intervention period
For each arm, 2 participants were lost to follow up, and 2 participants were removed from the study for not following the protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Flavia S. Lakschevitz, DDS, PhD, MSc | The University of Texas Health Science Center at Houston | 604-822-3863 | flavia.lakschevitz@dentistry.ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2017 | Sep 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| C015101 | cytidylyl-(3'-5')-cytidine |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
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| Xylitol only chewing gum | Drug | All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
|
| day 1 |
| Degree of Gingivitis as Assessed by the Gingival Index (GI) | Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
| day 22 |
| Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
| day 1 |
| Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for all teeth is calculated, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
| day 22 |
| day 1 |
| Discoloration of Teeth as Assessed by the Vita Scale | Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration. | day 22 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
| OG001 | Xylitol Only Chewing Gum | Xylitol only chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. |
|
|
| Primary | Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index | Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 22 |
|
|
|
| Primary | Degree of Gingivitis as Assessed by the Gingival Index (GI) | Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 1 |
|
|
|
| Primary | Degree of Gingivitis as Assessed by the Gingival Index (GI) | Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 22 |
|
|
|
| Primary | Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 1 |
|
|
|
| Primary | Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for all teeth is calculated, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
| For each arm, 2 participants were lost to follow up. Also, for each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | day 22 |
|
|
|
| Secondary | Discoloration of Teeth as Assessed by the Vita Scale | Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration. | For each arm, data were not collected for 7 participants (2 of which were lost to follow up), and 2 other participants did not follow the protocol and their data were not analyzed. | Posted | Count of Participants | Participants | day 1 |
|
|
|
| Secondary | Discoloration of Teeth as Assessed by the Vita Scale | Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration. | Data were not collected for 5 in the Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum arm (2 of which were lost to follow up). Data also were not collected for 3 in the Xylitol only chewing gum arm (2 of which were lost to follow up). For each arm, 2 other participants did not follow the protocol, and their data were not analyzed. | Posted | Count of Participants | Participants | day 22 |
|
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| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Xylitol Only Chewing Gum | Xylitol only chewing gum will be used for a period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D003741 |
| Dental Deposits |
| D014076 | Tooth Diseases |
| A3 |
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| A3.5 |
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| A4 |
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| B1 |
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| B2 |
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| B3 |
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| B4 |
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| C1 |
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| C2 |
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| C3 |
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| C4 |
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| D2 |
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| D3 |
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| D4 |
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| A3 |
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| A3.5 |
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| A4 |
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| B1 |
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| B2 |
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| B3 |
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| B4 |
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| C1 |
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| C2 |
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| C3 |
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| C4 |
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| D2 |
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| D3 |
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| D4 |
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