Clinical Research Study to Assess the Efficacy of Two Brushing Regimens

Gingivitis Clinical Trial

Official title:

Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Dental Plaque and Aid of Gum Problems

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240481
• Other study ID #: CRO-2024-02-PG-MRG-SP-BGS
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 12, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: January 2024
• Source: Colgate Palmolive
• Contact: Augusto R Elias-Boneta, DMD, MSD
• Phone: 1 (787) 554-0559
• Email: augustoelias[@]dentalresearchassociates.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

Drug:
• Test Regimen
toothpaste & mouthwash
• Control Regimen
toothpaste

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quigley and Hein Plaque Index	reductions in dental plaque	Baseline, 3 weeks, 6 week & 12 weeks
Primary	Loe and Silness Gingival Index	assessment of gum problems (gingival scores)	Baseline, 3 weeks, 6 week & 12 weeks