Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

Colgate-Palmolive

Status and phase: Enrolling; Phase 3

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Control Regimen; Drug: Test Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06240481

CRO-2024-02-PG-MRG-SP-BGS

Details and patient eligibility

About

The objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form.
• Male and female subjects aged 18-70 years, inclusive.
• Availability for the twelve-week duration of the clinical research study.
• Good general health based on the opinion of the study investigator
• Minimum of 20 permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 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

• Presence of orthodontic appliances.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
• 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.
• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
• History of alcohol and/or drug abuse.
• Self-reported pregnancy and/or lactating subjects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

Meridol ToothPaste Brush 2 x day / 2 mins Meridol Mouthwash (AmCl+Zn +NaF) Swish 15 mL / 30 secs after brushing

Treatment:

Drug: Test Regimen

Drug: Control Regimen

Group II

Placebo Comparator group

Description:

regular fluoride ToothPaste, Brush 2 x day 2 mins

Treatment:

Drug: Test Regimen

Drug: Control Regimen