Status:
COMPLETED
Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC)
Lead Sponsor:
Colgate Palmolive
Collaborating Sponsors:
Federal University of Pelotas
Conditions:
Dental Plaque
Dental Plaque Induced Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
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 flos...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06607172
Start Date
September 30 2024
End Date
October 22 2024
Last Update
December 13 2024
Active Locations (1)
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1
Federal University of Pelotas
Pelotas, Rio Grande do Sul, Brazil, 96015-560