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Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

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ClinicalTrials.gov Identifier: NCT03219840
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
CONFADENT Oral Technology, Kiss Industries LLC
Information provided by (Responsible Party):
Flavia S. Lakschevitz, The University of Texas Health Science Center, Houston

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gingivitis Plaque, Dental Periodontal Diseases Drug: CPC Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : June 20, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPC-Xylitol complex
Cetylpyridium Chloride (CPC) 0.09% + Xylitol chewing gum A All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Drug: CPC
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Other Names:
  • Cetylpyridium Chloride (CPC) Chewing Gum
  • CPC-Xylitol complex

Placebo Comparator: Placebo
Xylitol chewing gum B All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Drug: Placebo
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Other Name: Xylitol only Chewing Gum




Primary Outcome Measures :
  1. Plaque Index [ Time Frame: 21 days ]

    Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index(Turesky, Gilmore, and Glickman 1970), 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:

    Scores Criteria 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

  2. Gingivitis [ Time Frame: 21 days ]

    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:

    Scores Criteria 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.

  3. Bleeding sites on probing (BOP) [ Time Frame: 21 days ]

    The percent of bleeding sites on probing (BOP)(Ainamo and Bay 1975) as described in Ainamo & Bay, 1975, 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:

    Scores Criteria 0 Absence of bleeding after 30 seconds

    1. Bleeding after 30 seconds
    2. Immediate bleeding


Secondary Outcome Measures :
  1. Discoloration of teeth [ Time Frame: 21 days ]
    Objective observation of Discoloration of teeth will be recorded using a Vita 3D scale. Changes on baseline (day 1) and day 22 and will be annotated as none, slight to obvious.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219840


Locations
United States, Texas
University of Texas Health Science Center at Houston - School of Dentistry
Houston, Texas, United States, 77054
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
CONFADENT Oral Technology, Kiss Industries LLC
Investigators
Principal Investigator: Flavia Lakschevitz, DDS, PhD The University of Texas Health Science Center, Houston

Responsible Party: Flavia S. Lakschevitz, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03219840     History of Changes
Other Study ID Numbers: HSC-DB-17-0313
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Flavia S. Lakschevitz, The University of Texas Health Science Center, Houston:
Cetylpyridium Chloride (CPC)
Chewing Gum

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Gingivitis
Dental Plaque
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents