Clinical trial NCT06732466: Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Established Dental Plaque and Gingivitis
Official title: Clinical Research Study to Evaluate the Effect of a Toothpaste Containing Chlorhexidine 0.3% in Subjects With Established Dental Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gingivitis
Gingivitis and Periodontal Diseases
Gingival Disease
Dental Plaque
Keywords: chlorhexidine
toothpastes
gingivitis
dental plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2024-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III, one-center, parallel group, double blind and randomized trial
Primary purpose: TREATMENT

Brief summary: This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days.

Detailed description: This clinical study aims to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It is a Phase III study designed as randomized, one-center, double blind, parallel group trial involving 80 participants aged 18 to 70. Subjects will be divided into two groups: test group - subjects assigned to use a toothpaste with a 0.3% chlorhexidine + 3% AmCl and brush with a commercially available adult soft bristle toothbrush; negative control group - subjects assigned to use a placebo toothpaste without chlorhexidine and AmCl and brush with a commercially available adult soft bristle toothbrush. Subjects will undergo baseline, 14 days and 21 days evaluations. The primary outcome will be reduction of gingival inflammation and data will be analyzed using ANCOVA to assess the efficacy of the test product. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of the chlorhexidine toothpaste regarding gingivitis and dental plaque control.

Eligibility criteria: Inclusion Criteria:

* Males and females, between 18-70 years of age;
* Availability for the duration of the study;
* Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
* Willingness to provide information related to their medical history;
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
* Initial gingivitis index a minimum average score of 1.5 as determined by the use of the Löe and Silness Gingival Index;
* More than 30% of bleeding sites and absence of periodontal disease;
* Informed Consent Form signed.

Exclusion Criteria:

* Absence of visible clinical signs of periodontal disease, such as the presence of suppuration, dental mobility, and/or extensive attachment loss;
* That received dental prophylaxis within 1 month prior to the Baseline visit;
* Oral pathology or a history of allergy to testing products;
* Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
* Subject participating in any other clinical study;
* Subject pregnant or breastfeeding;
* Subject allergic to oral care products, personal care consumer products, or their ingredients;
* Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
* Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
* Current smokers and subjects with a history of alcohol or drug abuse;
* Subjects with orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations
* An existing medical condition (eg: diabetic people) which prohibits eating or drinking for periods up to 4 hours.

Primary outcomes:
measure: Löe-Silness Gingival Index
timeFrame: 21 days
Secondary outcomes:
measure: Modified Quigley-Hein Plaque Index
timeFrame: 21 days
measure: Lobene Stain index
timeFrame: 21 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Cassiano K Rosing, PhD
role: PRINCIPAL_INVESTIGATOR
References: