Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study
NCT ID: NCT02980497
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
370 participants
INTERVENTIONAL
2013-09-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Listerine Zero Mouthwash (without alcohol)
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.
Listerine Zero Mouthwash (without alcohol)
20 ml of rinse for 30 seconds, twice a day
Listerine Antiseptic Mouthwash (with alcohol)
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.
Listerine Antiseptic Mouthwash (with alcohol)
20 ml of rinse for 30 seconds, twice a day
Brush only
Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.
No interventions assigned to this group
Interventions
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Listerine Zero Mouthwash (without alcohol)
20 ml of rinse for 30 seconds, twice a day
Listerine Antiseptic Mouthwash (with alcohol)
20 ml of rinse for 30 seconds, twice a day
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
Yes
Sponsors
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University of Taubate
OTHER
Johnson & Johnson Consumer and Personal Products Worldwide
INDUSTRY
Responsible Party
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Principal Investigators
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Jose Cortelli, Ph. D
Role: PRINCIPAL_INVESTIGATOR
Universidade de Taubate
Sheila Cortelli, Ph.D
Role: STUDY_CHAIR
Universidade de Taubate
Locations
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University of Taubate
Taubaté, São Paulo, Brazil
Countries
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References
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Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6.
Other Identifiers
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FCLGBP0056
Identifier Type: -
Identifier Source: org_study_id