A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Dental Plaque Clinical Trial

Official title:

A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401360
• Other study ID #: 2012135
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: October 4, 2017
• Start date: April 2013
• Est. completion date: April 2013

Study information

• Verified date: October 2017
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• give written informed consent prior to their participation;

• be 18 to 65 years of age at the time of enrollment;

• agree not to participate in any other oral/dental product studies;

• agree to delay any elective dentistry (including a dental prophylaxis);

• agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;

• agree to return for the scheduled visits and follow study procedures;

• be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;

• have more than 10 bleeding sites at visits 1-3

• Consistency of bleeding site number at baseline may be considered;

• have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and

• refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion Criteria:

• teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus

• antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam

• medical conditions that the investigator considers significant and that may compromise the evaluation of study results

• currently participating in any other clinical trial

• participated in a clinical trial for plaque/gingivitis within the previous 30 days

• pregnant or lactating

• orthodontic appliances or removable partial dentures

• soft or hard tissue tumor of the oral cavity

• advanced periodontal disease

• history of hepatitis, diabetes, or other communicable diseases

• history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures

• history of significant adverse effects following the use of oral hygiene products such as toothpaste

• oral pathoses that could interfere with compliance and/or examinations or that need treatment.

Related Conditions & MeSH terms

• Dental Gingivitis
• Dental Plaque
• Gingivitis

Intervention

Drug:
• China Crest® Pro-health 7 Complete Toothpaste
Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
• China Crest® Cavity Protection Toothpaste
Crest® meliliangje manual toothbrush

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 0
Primary	Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 3
Primary	Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 10
Primary	Gingivitis	Gingivitis was assessed according to the Gingival Bleeding Index	Day 24
Secondary	Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 0
Secondary	Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 3
Secondary	Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 10
Secondary	Plaque Examination	The Modified Turesky Plaque Index was used to examine plaque.	Day 24