Trial Outcomes & Findings for Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis (NCT NCT03219840)
NCT ID: NCT03219840
Last Updated: 2021-02-08
Results Overview
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 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
COMPLETED
PHASE4
70 participants
day 1
2021-02-08
Participant Flow
1 participant was enrolled but then was lost to follow up before randomization.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
31
|
|
Overall Study
Day 1 Visit for 1st Period
|
37
|
31
|
|
Overall Study
1st Intervention Period of 21 Days
|
34
|
31
|
|
Overall Study
Day 22 Visit for 1st Period
|
34
|
31
|
|
Overall Study
Washout Period of 21 Days
|
34
|
31
|
|
Overall Study
Day 1 Visit for 2nd Period
|
34
|
31
|
|
Overall Study
2nd Intervention Period of 21 Days
|
34
|
31
|
|
Overall Study
Day 22 Visit for 2nd Period
|
34
|
31
|
|
Overall Study
COMPLETED
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=69 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: day 1Population: 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.
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 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
|
0.41 score on a scale
Standard Deviation 0.28
|
0.43 score on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: day 22Population: 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.
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 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
|
0.36 score on a scale
Standard Deviation 0.26
|
0.35 score on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: day 1Population: 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.
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. 1. Mild inflammation - slight change in color and little change in texture. 2. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. 3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Gingivitis as Assessed by the Gingival Index (GI)
|
0.16 score on a scale
Standard Deviation 0.41
|
0.19 score on a scale
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: day 22Population: 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.
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. 1. Mild inflammation - slight change in color and little change in texture. 2. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. 3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Gingivitis as Assessed by the Gingival Index (GI)
|
0.21 score on a scale
Standard Deviation 0.64
|
0.15 score on a scale
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: day 1Population: 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.
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 1. Bleeding after 30 seconds 2. Immediate bleeding
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
|
0.09 score on a scale
Standard Deviation 0.06
|
0.11 score on a scale
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: day 22Population: 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.
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 1. Bleeding after 30 seconds 2. Immediate bleeding
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=65 Participants
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.
|
Xylitol Only Chewing Gum
n=65 Participants
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.
|
|---|---|---|
|
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
|
0.08 score on a scale
Standard Deviation 0.08
|
0.09 score on a scale
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: day 1Population: 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.
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.
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=60 Participants
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.
|
Xylitol Only Chewing Gum
n=60 Participants
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.
|
|---|---|---|
|
Discoloration of Teeth as Assessed by the Vita Scale
A1
|
28 Participants
|
30 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A2
|
21 Participants
|
19 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A3
|
4 Participants
|
1 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A3.5
|
0 Participants
|
3 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B1
|
6 Participants
|
6 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B2
|
1 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B3
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C1
|
0 Participants
|
1 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C2
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C3
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D2
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D3
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 22Population: 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.
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.
Outcome measures
| Measure |
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
n=62 Participants
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.
|
Xylitol Only Chewing Gum
n=64 Participants
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.
|
|---|---|---|
|
Discoloration of Teeth as Assessed by the Vita Scale
B2
|
0 Participants
|
1 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B3
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C1
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C2
|
0 Participants
|
1 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C3
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
C4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D2
|
0 Participants
|
1 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D3
|
1 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
D4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A1
|
25 Participants
|
27 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A2
|
24 Participants
|
22 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A3
|
3 Participants
|
2 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A3.5
|
1 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
A4
|
0 Participants
|
0 Participants
|
|
Discoloration of Teeth as Assessed by the Vita Scale
B1
|
8 Participants
|
10 Participants
|
Adverse Events
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol Chewing Gum
Xylitol Only Chewing Gum
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Flavia S. Lakschevitz, DDS, PhD, MSc
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place