A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation

NCT02233998 | Completed Results

• 1 other identifier: CO-140508133810-OCCT
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse. 165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.

Conditions

Plaque; Gingivitis

Keywords

Plaque; Bleeding; Gums; Gingiva; Gingival Inflammation; Gingival Bleeding

Outcome Measures

Primary Outcomes (2)

• Whole Mouth Mean Modified Gingival Index (MGI) at Week 3

  Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.

  3 Weeks

• Whole Mouth Mean Plaque Index (PI) at Week 3

  Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.

  3 Weeks

Secondary Outcomes (7)

• Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3

  3 Weeks

• Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3

  Baseline to 3 Weeks

• Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3

  Baseline to 3 Weeks

• Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3

  Baseline to 3 Weeks

• Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3

  Baseline to 3 Weeks

Study Arms (3)

Mouth Rinse 1

ACTIVE COMPARATOR

After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.

Other: Mouth Rinse 1

Mouth Rinse 2

ACTIVE COMPARATOR

After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.

Other: Mouth Rinse 2

Mouth Rinse 3

PLACEBO COMPARATOR

After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds.

Other: Mouth Rinse 3

Interventions

Mouth Rinse 1 OTHER

Also known as: Cool Mint Listerine Antiseptic

Mouth Rinse 1

Mouth Rinse 2 OTHER

Also known as: Listerine Zero

Mouth Rinse 2

Mouth Rinse 3 OTHER

Also known as: Placebo

Mouth Rinse 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
• Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial;
• Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products;
• A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count;
• A mean gingival index ≥ 1.95 according to the Modified Gingival Index;
• A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth;
• Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator;
• Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
• Absence of fixed or removable orthodontic appliance or removable partial dentures;
• Able to read and understand the local language;
• Male or non-pregnant, non-lactating female, by self-report;
• Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Baseline visit.
• Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
• Abstinence from reproductive intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
• Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring);

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouth rinses and red food dye;
• Dental prophylaxis within 2 weeks prior to Screening visit;
• Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one month prior to the baseline exam;
• Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses within three weeks prior to baseline;
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
• Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator;
• Participation in any other clinical study within 30 days of Visit 1;
• Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each); and
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, substance or alcohol abuse or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L4W0C2, Canada

Location

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis; Hemorrhage; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael Lynch, DMD, PhD/Study Director
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

mlynch23@its.jnj.com

908-433-6423 USA EST

Study Officials

• Maher Naji, D.D.S

  All Sum Research Center Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 21, 2015
• Results First Posted: July 28, 2015

Record last verified: 2015-07

Locations

CA (1)