A Clinical Trial to Test the Effect of an Experimental Mouth Rinse on Gum Disease

NCT01821261 | Withdrawn FDA Device

• 1 other identifier: LAEBBA0004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects will be given special instructions about eating, smoking and taking care of their teeth during the 18 hours before they come to the dentist's office for screening. At that first visit, they will be examined by a dentist, who will examine their mouths with a dental instrument to determine whether they qualify to participate in the trial. Someone who works for the dentist will also take some oral measurements. Participants who qualify to be in the study will receive a treatment for their gingivitis and have an equal chance of being assigned to one of three treatment groups. Subjects in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily with a one-inch strip of toothpaste in their regular manner. After brushing, subjects in one group will use an experimental mouth rinse that is not available in stores. Another group will be given a mouth rinse to use that is already available in stores, and the third group will not use any mouth rinse at all. After they receive their assigned products subjects will be supervised while they brush their teeth and/or rinse to ensure they understand exactly how to use the products. All other brushing and rinsing over the next three months will be at home, but subjects will be required to keep a diary to record their brushing and rinsing times twice each day. Subjects will be required to bring their diaries and any leftover toothpaste and mouth rinse with them for four more scheduled appointments after about 1 week, 2 weeks, 4 weeks, and 3 months. At those appointments, the dentist will examine their mouths, make sure there are no safety concerns, and examine again to get the measurements needed. One of the dentist's staff members will take other measurements as well. The study will determine the measured effects of the experimental mouth rinse on gingivitis, and compare these results to the mouth rinse that is already available, as well as to using no mouth rinse at all.

Conditions

Gingivitis

Keywords

Gums; Gingiva; Gingival Inflammation; Gingival Bleeding

Outcome Measures

Primary Outcomes (1)

• Whole-mouth Mean Bleeding Index (BI) at 3 Months

  Bleeding after periodontal probe will be assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.

  3 months

Secondary Outcomes (9)

• Whole-mouth Mean Bleeding Index (BI)

  within 4 weeks

• Whole-mouth Mean Modified Gingival Index (MGI)

  within 3 months

• Whole Mouth Mean Plaque Index (PI)

  within 3 months

• Mean Area Stain Score for Mesial Region

  within 3 months

• Mean Area Stain Score for Gingival Region

  within 3 months

Study Arms (3)

Mouth Rinse 19668-012

EXPERIMENTAL

Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 20 ml of mouth rinse 19668-012 for 30 seconds and spit it out - do not swallow.

Device: Mouth Rinse 19668-012; Drug: Toothpaste 035000513007

Mouth Rinse 500347078842

ACTIVE COMPARATOR

Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 10 ml of mouth rinse 500347078842 for 60 seconds and spit it out - do not swallow. Attention: Toothpastes can stop mouth rinse from working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using the mouth rinse. You can also use the mouthwash at a different time of day.

Drug: Mouth Rinse 500347078842; Drug: Toothpaste 035000513007

Toothpaste 035000513007

OTHER

Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner. Subjects in this arm will not use any mouth rinse.

Drug: Toothpaste 035000513007

Interventions

Mouth Rinse 19668-012 DEVICE

20 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily

Mouth Rinse 19668-012

Mouth Rinse 500347078842 DRUG

10 ml of mouth rinse 500347078842 for 60 seconds, twice daily

Also known as: Mouth rinse containing Chlorhexidine, Corsodyl Mouthwash

Mouth Rinse 500347078842

Toothpaste 035000513007 DRUG

Approximately one inch of toothpaste 035000513007, twice daily

Also known as: Toothpaste containing fluoride, Colgate® Cavity Protection Regular

Mouth Rinse 19668-012; Mouth Rinse 500347078842; Toothpaste 035000513007

Eligibility Criteria

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

You may qualify if:

• Assessed by site personnel as able to comprehend and follow the requirements of the study in the Portuguese language, and to be available on scheduled visit dates
• After being informed of all pertinent aspects of the trial, and having all questions answered, voluntarily signed an informed consent document
• Assessed by the investigator to have gingivitis, and otherwise qualify to be a participant in the trial

You may not qualify if:

• Relative, partner or staff of any clinical research site personnel
• Any oral, psychiatric or medical condition (including pregnancy or nursing), laboratory abnormality, or use of experimental or other products that may (per protocol or in the opinion of the investigator) compromise the safety of the participant or the interpretation of study results

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

MeSH Terms

Conditions

Gingivitis; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Lynch, DMD, PhD

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 29, 2013
• Study Start: April 30, 2014
• Primary Completion: April 30, 2014
• Study Completion: July 31, 2014
• Last Updated: January 28, 2019

Record last verified: 2019-01