Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

Launched by COLGATE PALMOLIVE · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different brushing methods over a period of twelve weeks to see which one is better at reducing dental plaque and improving gum health. The two methods being compared are one that uses a special toothpaste and mouthwash with sodium fluoride and zinc, and the other that uses regular fluoride toothpaste. The goal is to find out which approach helps keep teeth cleaner and gums healthier.

To participate in this study, you need to be between the ages of 18 and 70 and have at least 20 natural teeth. You should also have some level of gum inflammation (gingivitis) and plaque buildup. However, certain conditions, like having braces, dentures, or severe gum disease, would prevent you from joining. If you decide to take part, you’ll be expected to commit to the study for the full twelve weeks, and you'll receive guidance on how to follow the brushing regimen. This trial could help improve dental care practices and contribute to better oral health for everyone.

Gender

ALL

Eligibility criteria

• 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.