Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Colgate Palmolive
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
Overview
Brief Summary
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.
Participants will:
- Brush and rinse twice a day with the designated products for 6 months
- Visit the clinic once every 3 months after baseline for reassessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female subjects aged 18-70 years, inclusive.
- •Availability for the 6-month duration of the clinical research study.
- •Good general health based on the opinion of the study investigator.
- •Signed Informed Consent Form.
- •Minimum of 20 natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Exclusion Criteria
- •Be under orthodontic treatment.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Participants with current moderate or severe periodontitis (periodontitis screening index \[PSI\] \>2 in more than 2 sextants or PSI \>3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
- •Five or more carious lesions requiring immediate restorative treatment.
- •Antibiotic use any time during the one-month period prior to entry into the study.
- •Participation in any other clinical study or test panel within the one month prior to entry into the study.
- •Dental prophylaxis during the past two weeks prior to baseline examinations.
- •History of allergies to oral care/personal care consumer products or their ingredients.
- •On any prescription medicines that might interfere with the study outcome based on the examiner/PI opinion.
Arms & Interventions
Test Group
Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
Intervention: Test Mouthrinse (Other)
Control Group
subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
Intervention: Control Mouthrinse (Other)
Outcomes
Primary Outcomes
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
Time Frame: 6-month period
Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.
Secondary Outcomes
- Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups(6-month period)