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

Phase 3

Active, not recruiting

• Conditions: Gingivitis; Plaque
• Interventions: Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F); Drug: manual toothbrush + Colgate dental cream

• Registration Number: NCT06244303
• Lead Sponsor: Colgate Palmolive

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-22
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)	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
Group I	manual toothbrush + Colgate dental cream	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
Group II	manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)	Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins
Group II	manual toothbrush + Colgate dental cream	Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins

Primary Outcome Measures

Name	Time	Method
Quigley and Hein Plaque Index	Baseline, 1-, 3-, 6-, and 12-week	reductions in dental plaque
Loe and Silness Gingival Index	Baseline, 1-, 3-, 6-, and 12-week	reductions in gingivitis

Trial Locations

Locations (1)

Mesa Dental Centre; 🇺🇸 Costa Mesa, California, United States