Status:
COMPLETED
A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Plaque
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 v...
Detailed Description
A sufficient number of generally healthy subjects (approximately 165) that meet the required inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center, randomized, pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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);
- Intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy); and
- A female subject who is postmenopausal (i.e., amenorrheic for at least 12 months prior to the Baseline visit) is not considered of reproductive potential.
- Willing for this to be the only investigational product used during this time period; and
- Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT02233998
Start Date
August 1 2014
End Date
September 1 2014
Last Update
August 21 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All Sum Research Center Ltd.
Mississauga, Ontario, Canada, L4W0C2