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

NCT06607172 | Completed Phase 3 DMC

• 1 other identifier: CRO 2024-06-WF-POC-BZ-CB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Plaque; Dental Plaque Induced Gingivitis; Dental Plaque and Gingivitis; Gingivitis

Keywords

dental hygiene products; gingivitis; dental plaque; oral irrigator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Navy Plaque Index, Rustogi Modification

  3 weeks

Study Arms (3)

Group II: waterflosser + dilutable 0.075% CPC

ACTIVE COMPARATOR

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; Drug: Cetylpyridinium Chloride (CPC)

Group III: negative control

NO INTERVENTION

Subjects assigned to this group will abstain for any oral hygiene during the 21 days of follow-up.

Group I: water flosser and water

EXPERIMENTAL

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

Interventions

oral irrigator DEVICE

water flosser device

Group I: water flosser and water

Cetylpyridinium Chloride (CPC) DRUG

Cetylpyridinium 0.075%

Group II: waterflosser + dilutable 0.075% CPC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Pelotas: collaborator

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

Cetylpyridinium

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wilker Muniz, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, examiner blind, parallel-group clinical trial

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: September 30, 2024
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)