Clinical trial NCT06607172: Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC)
Official title: Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC): a Randomized Clinical Trial with Experimental Gingivitis Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Dental Plaque Induced Gingivitis
Dental Plaque and Gingivitis
Gingivitis
Keywords: dental hygiene products
gingivitis
dental plaque
oral irrigator
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: Federal University of Pelotas
First posted: 2024-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, examiner blind, parallel-group clinical trial
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Löe-Silness Gingival Index
timeFrame: 3 weeks
Secondary outcomes:
measure: Navy Plaque Index, Rustogi Modification
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Wilker Muniz, PhD
role: PRINCIPAL_INVESTIGATOR
References: