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

NCT ID: NCT06607172

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2024-10-22

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.

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.

Conditions

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

Keywords

dental hygiene products; gingivitis; dental plaque; oral irrigator

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

oral irrigator

Intervention Type: DEVICE

water flosser and 0.075% CPC

Cetylpyridinium Chloride (CPC)

Intervention Type: DRUG

Cetylpyridinium 0.075%

Group III: negative control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

oral irrigator

Intervention Type: DEVICE

water flosser device

Interventions

oral irrigator

water flosser device

Intervention Type: DEVICE

oral irrigator

water flosser and 0.075% CPC

Intervention Type: DEVICE

Cetylpyridinium Chloride (CPC)

Cetylpyridinium 0.075%

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilker Muniz, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

CRO 2024-06-WF-POC-BZ-CB

Identifier Type: -

Identifier Source: org_study_id