Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.

Colgate-Palmolive

Status and phase: Active, not recruiting; Phase 3

Conditions: Plaque; Gingivitis

Treatments: Drug: manual toothbrush + Colgate dental cream; Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06244303

CRO-2023-11-PG-DWN-CA-BGS

Details and patient eligibility

About

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Enrollment: 82 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: Double Blind

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82 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs

Treatment:

Drug: manual toothbrush + Colgate dental cream

Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)

Group II

Placebo Comparator group

Description:

Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins

Treatment:

Drug: manual toothbrush + Colgate dental cream

Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)