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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
70
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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 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
Time frame: 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 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
Time frame: 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. 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.
Time frame: 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. 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.
Time frame: 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 1. Bleeding after 30 seconds 2. Immediate bleeding
Time frame: 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 1. Bleeding after 30 seconds 2. Immediate bleeding
Time frame: day 22
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.
Time frame: 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.
Time frame: day 22
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