A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning

NCT01462110 | Completed Results DMC FDA Device

• 1 other identifier: LAEBBA0001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit. At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing. If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used. You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.

Conditions

Dental Plaque

Keywords

Gingivitis; Microorganisms

Outcome Measures

Primary Outcomes (2)

• Whole-mouth Mean Modified Gingival Index (MGI)

  Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.

  4 weeks

• Whole-mouth Mean Plaque Index (PI)

  Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.

  4 weeks

Secondary Outcomes (6)

• Whole-mouth Mean Modified Gingival Index (MGI)

  2 weeks

• Whole-mouth Mean Plaque Index (PI)

  2 Weeks

• Whole-mouth Mean Bleeding Index (BI)

  2 Weeks

• Whole-mouth Mean Bleeding Index (BI)

  4 Weeks

• Microbiological Assessments - Absolute Counts

  4 weeks

Study Arms (2)

0.15% ethyl lauroyl arginate HCl-containing mouthrinse

EXPERIMENTAL

Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.

Device: 19416-154-1

5% hydroalcohol mouthrinse

SHAM COMPARATOR

Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.

Device: W002194-0221P

Interventions

19416-154-1 DEVICE

0.15% ethyl lauroyl arginate HCl-containing mouthrinse

Also known as: Not Marketed

0.15% ethyl lauroyl arginate HCl-containing mouthrinse

W002194-0221P DEVICE

5% hydroalcohol mouthrinse

Also known as: Not Marketed

5% hydroalcohol mouthrinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years of age and in good general health.
• Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
• Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained.
• Must be willing to use the products according to instructions and be available for appointments.
• Baseline dental measurements meet protocol-specified criteria.
• Willingness to refrain from using all oral hygiene procedures within 12-18 hours prior to each visit.
• Refrain from eating, drinking or smoking for four hours prior to each visit.

You may not qualify if:

• Lip, tongue, or other form of oral piercing.
• Fixed or removable orthodontic appliance (such as bridges, braces or dentures).
• Pregnancy or breast-feeding at any time during the trial.
• Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

BioSci Research Inc.

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Results Point of Contact

• Title: Michael Lynch
• Organization: Johnson & Johnson Consumer Inc.

mlynch23@ITS.JNJ.com

908-433-6423

Study Officials

• Marcelo Araujo, DDS, MS, PhD

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 31, 2011
• Study Start: November 1, 2011
• Primary Completion: December 2, 2011
• Study Completion: December 2, 2011
• Last Updated: April 7, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)