Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC) (WFPOC)

Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC): a Randomized Clinical Trial with Experimental Gingivitis Model

This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Dental Plaque; Dental Plaque Induced Gingivitis; Dental Plaque and Gingivitis
• Intervention / Treatment: Device: oral irrigator; Device: oral irrigator; Drug: Cetylpyridinium Chloride (CPC)

Detailed Description

This is an examiner blind, randomized controlled, parallel designed clinical study that aims to assess the gum health efficacy (antiplaque and antigingivitis) from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene in a 3-week experimental gingivitis. Thirty participants will be enrolled and allocated into 3 groups: group I - using a water flosser device and water each time; group II - using a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time (for groups I an II participants will use this regimen treatment twice daily, in the morning and evening, and no other oral hygiene will be allowed during the 21 days of follow-up); group III - negative control in which participants will abstain for any oral hygiene during the 21 days of follow-up. Gingival index measurements will be the primary efficacy variable after using the assigned regimen for 3 weeks for each subject. Subjects will under go baseline, 3 days, 1, 2 and 3 weeks visits. An Analysis of Covariance will be performed on the final or delta plaque scores using the baseline value as covariate. The F-test in this analysis will test the hypothesis that the waterflosser groups are equal in adjusted means.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015-560
      • Federal University of Pelotas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signed informed consent form;
• Aged between 18 and 70;
• Available for the three (3) week study duration;
• Good general health for participation in the study, based on the opinion of the study investigator;
• Must have at least 20 natural permanent teeth;
• Teeth must meet the scoring entry criteria for dental plaque and gingivitis (gum inflammation) at the discretion of the study examiner.

Exclusion Criteria:

• Medical condition which requires premedication prior to dental visits/procedures;
• Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations;
• Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months;
• Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care;
• Abnormalities/diseases of the soft or hard oral tissues;
• Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
• Use of drugs that can affect salivary flow;
• Use of antibiotics three (3) months prior to study entry and/or during participation in this study;
• Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion;
• Self-reported pregnancy and/or breastfeeding;
• Current Participation in another clinical study or during the month prior to this clinical study entry;
• Known allergies and/or reactions to common dentifrice ingredients;
• Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
• Immunocompromised conditions (AIDS, immunosuppressive drug therapy);
• Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group II: waterflosser + dilutable 0.075% CPC; Subjects assigned to this group will use a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up.	Device: oral irrigator; water flosser device; Device: oral irrigator; water flosser and 0.075% CPC; Drug: Cetylpyridinium Chloride (CPC); Cetylpyridinium 0.075%
No Intervention: Group III: negative control; Subjects assigned to this group will abstain for any oral hygiene during the 21 days of follow-up.
Experimental: Group I: water flosser and water; Subjects assigned to this group will use a water flosser device and water each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up.	Device: oral irrigator; water flosser device; Device: oral irrigator; water flosser and 0.075% CPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Löe-Silness Gingival Index	A Löe-Silness Gingival Index score from 0 to 3 (0 = absence of inflammation and 3 = severe inflammation) will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth (6 sites/tooth) using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navy Plaque Index, Rustogi Modification	The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. This index includes nine surfaces (marked A-I) examined for plaque after staining. Surfaces A, B, C denote the gingival margin surfaces, surfaces D and F the proximal surfaces. The total plaque score range is 0-9, the range for the gingival margin area is 0-3 and for the proximal area 0-2.	3 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Collaborators: Federal University of Pelotas
• Investigators: Principal Investigator: Wilker Muniz, PhD, Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: gingivitis; dental plaque; oral irrigator; dental hygiene products
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Gingival Diseases; Dental Deposits; Dental Plaque; Gingivitis; Anti-Infective Agents; Anti-Infective Agents, Local; Cetylpyridinium
• Other Study ID Numbers: CRO 2024-06-WF-POC-BZ-CB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No