Clinical trial NCT06598072: Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen With CPC+Zn, Flossing and Brushing, and an Alcohol-based Mouthwash Regimen With Essential Oils in Reducing Plaque and Gingivitis.
Official title: Clinical Study to Evaluate the Efficacy of a Regimen Including Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and Brushing and a Regimen Including Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Bleeding
Plaque Induced Gingival Disease
Gingival Diseases
Gingivitis and Periodontal Diseases
Keywords: gingivitis
dental plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: Universidad Autonoma de San Luis Potosí
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase III, randomized, controlled, double-blind, parallel-group clinical trial
Primary purpose: TREATMENT

Brief summary: This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and to rising with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.

Detailed description: This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 groups: one - using the CPC+Zn mouthwash, another using the essential oils mouthwash and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. 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 these oral hygiene regimens.

Eligibility criteria: Inclusion Criteria:

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; At least 20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; At least 10 bleeding sites based on the Bleeding Index (BI); Initial mean gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index (MGI); Subjects without allergies to the products that are being tested; Informed Consent Form signed.

Exclusion Criteria:

No sites with more than 5 mm probing depth, and a maximum of three sites of 5 mm probing depth.

Have received dental prophylaxis within 1 month prior to the Baseline visit; Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study; Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline; Use of smokeless tobacco; Any other condition that would make the volunteer inappropriate for the study. Oral pathology, chronic disease, 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; Subject participating in any other clinical study; Subject pregnant or breastfeeding; Subject allergic to oral care products, personal care consumer products, or their ingredients; Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine); Periodontal treatment 12 months before the beginning of the study; 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

Primary outcomes:
measure: Modified Gingival Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Turesky modification of Quigley-Hein Plaque Index
timeFrame: 12 weeks
measure: Bleeding on probing
timeFrame: 12 weeks
measure: Probing depth
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Universidad Autónoma de San Luis Potosí
state: SLP
Study officials:
References: