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Completed

NCT Number: NCT03219840

Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

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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Key information

Conditions

Gingivitis Dental Deposits Dental Plaque Gingival Diseases Infections Mouth Diseases Periodontal Diseases Plaque, Dental Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be aged 18 and older
  • Be capable of giving informed consent themselves and are able and willing to participate in the study
  • Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
  • Patients that regularly brush their teeth twice a day

Exclusion criteria

  • Pregnant or breastfeeding women
  • Patients taking long-term anti-microbial or anti-inflammatory drugs
  • Patients unable or unwilling to provide informed consent
  • Self-reported use of tobacco products
  • Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
  • Less than 26 teeth in the mouth
  • Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
  • Periodontitis as indicated periodontal pockets greater than 5 millimeters on more than one site
  • Inability to comply with assigned treatment regimen

Treatment and study plan

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.

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.

Primary outcomes

  1. Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index

    Time frame: day 1

    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

    • Separate flecks of plaque at the cervical margin of the tooth
    • A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
    • A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    • Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    • Plaque covering two-thirds or more of the crown of the tooth

  2. Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index

    Time frame: day 22

    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

    • Separate flecks of plaque at the cervical margin of the tooth
    • A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
    • A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    • Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    • Plaque covering two-thirds or more of the crown of the tooth

  3. Degree of Gingivitis as Assessed by the Gingival Index (GI)

    Time frame: day 1

    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.

    • Mild inflammation - slight change in color and little change in texture.
    • Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure.
    • Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.

  4. Degree of Gingivitis as Assessed by the Gingival Index (GI)

    Time frame: day 22

    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.

    • Mild inflammation - slight change in color and little change in texture.
    • Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure.
    • Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.

  5. Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index

    Time frame: day 1

    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

    • Bleeding after 30 seconds
    • Immediate bleeding

  6. Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index

    Time frame: day 22

    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

    • Bleeding after 30 seconds
    • Immediate bleeding

Secondary outcomes

  1. Discoloration of Teeth as Assessed by the Vita Scale

    Time frame: day 1

    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.

  2. Discoloration of Teeth as Assessed by the Vita Scale

    Time frame: day 22

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • CONFADENT Oral Technology, Kiss Industries LLC

Registry information

Official study title

Effects of Cetylpyridium Chloride (CPC) Based Chewing Gum Plus Tooth Brushing on Plaque Formation and Gingivitis: a Randomized, Double-Blind, Crossover, Placebo-controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2017
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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