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NCT03219840 · ClinicalTrials.gov registry record · Phase 4
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT03219840: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03219840 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219840, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum
- DRUG Xylitol only chewing gum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2018-09-08 |
| Phase | Phase 4 |
What the finished NCT03219840 record still lists
NCT03219840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum is the first listed.
NCT03219840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03219840 about?
NCT03219840 is a clinical study titled "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 th...
What is the current status of trial NCT03219840?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2017-10-18. Estimated completion is 2018-09-08.
What interventions are being tested in trial NCT03219840?
The interventions under investigation include: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum (DRUG), Xylitol only chewing gum (DRUG).
Who is sponsoring clinical trial NCT03219840?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03219840's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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