Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study

Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study

Sponsors

Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Collaborator: University of Taubate

Source Johnson & Johnson Consumer and Personal Products Worldwide
Brief Summary

The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.

Overall Status Completed
Start Date 2013-09-01
Completion Date 2014-03-01
Primary Completion Date 2014-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Modified Gingival Index (MGI) at 6 Months 6 Months
Secondary Outcome
Measure Time Frame
Mean Modified Gingival Index (MGI) at 1 Month 1 Month
Mean Modified Gingival Index (MGI) at 3 Months 3 Months
Mean Gingival Bleeding Index (BI) at 1 Month 1 Month
Mean Gingival Bleeding Index (BI) at 3 Months 3 Months
Mean Gingival Bleeding Index (BI) at 6 Months 6 Months
Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month 1 Month
Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months 3 Months
Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months 6 Months
Enrollment 370
Condition
Intervention

Intervention Type: Other

Intervention Name: Listerine Zero Mouthwash (without alcohol)

Description: 20 ml of rinse for 30 seconds, twice a day

Arm Group Label: Listerine Zero Mouthwash (without alcohol)

Intervention Type: Other

Intervention Name: Listerine Antiseptic Mouthwash (with alcohol)

Description: 20 ml of rinse for 30 seconds, twice a day

Arm Group Label: Listerine Antiseptic Mouthwash (with alcohol)

Eligibility

Criteria:

Inclusion Criteria: 1. Males and females 18 years of age or older, in good general and oral health, except gingivitis. 2. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 3. 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. 4. 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. 5. A mean gingival index ≥ 1.75 according to the Modified Gingival Index. 6. A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth. 7. Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator. 8. Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV). 9. Absence of fixed or removable orthodontic appliance or removable partial dentures. Exclusion Criteria: 1. History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye. 2. History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject. 3. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. 4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam. 5. Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline. 6. Current or history of alcohol or drug abuse. 7. Self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility: University of Taubate
Location Countries

Brazil

Verification Date

2016-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Listerine Zero Mouthwash (without alcohol)

Type: Active Comparator

Description: Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds.

Label: Listerine Antiseptic Mouthwash (with alcohol)

Type: Active Comparator

Description: Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds.

Label: Brush only

Type: No Intervention

Description: Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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