Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

Phase 3

Not yet recruiting

• Conditions: Dental Plaque; Gingivitis
• Interventions: Drug: Test Regimen; Drug: Control Regimen

• Registration Number: NCT06240481
• Lead Sponsor: Colgate Palmolive

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Study Start: 2024-02-12
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 II	Control Regimen	regular fluoride ToothPaste, Brush 2 x day 2 mins
Group I	Test Regimen	Meridol ToothPaste Brush 2 x day / 2 mins Meridol Mouthwash (AmCl+Zn +NaF) Swish 15 mL / 30 secs after brushing
Group II	Test Regimen	regular fluoride ToothPaste, Brush 2 x day 2 mins
Group I	Control Regimen	Meridol ToothPaste Brush 2 x day / 2 mins Meridol Mouthwash (AmCl+Zn +NaF) Swish 15 mL / 30 secs after brushing

Primary Outcome Measures

Name	Time	Method
Quigley and Hein Plaque Index	Baseline, 3 weeks, 6 week & 12 weeks	reductions in dental plaque
Loe and Silness Gingival Index	Baseline, 3 weeks, 6 week & 12 weeks	assessment of gum problems (gingival scores)

Trial Locations

Locations (1)

Clinica Dental Dr. Sitges; 🇪🇸 Manresa, Spain