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

• ClinicalTrials.gov Identifier: NCT02980497
• Recruitment Status: Completed
• First Posted: December 2, 2016
• Last Update Posted: December 2, 2016
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Collaborator: University of Taubate
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plaque; Gingivitis; Gum Inflammation; Bleeding	Other: Listerine Zero Mouthwash (without alcohol); Other: Listerine Antiseptic Mouthwash (with alcohol)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 370 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study
• Study Start Date: September 2013
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: Listerine Zero Mouthwash (without alcohol); 20 ml of rinse for 30 seconds, twice a day
Active Comparator: 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.	Other: Listerine Antiseptic Mouthwash (with alcohol); 20 ml of rinse for 30 seconds, twice a day
No Intervention: Brush only; Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.

Outcome Measures

Primary Outcome Measures :

1. Mean Modified Gingival Index (MGI) at 6 Months [ Time Frame: 6 Months ]
   Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.

Secondary Outcome Measures :

1. Mean Modified Gingival Index (MGI) at 1 Month [ Time Frame: 1 Month ]
   Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
2. Mean Modified Gingival Index (MGI) at 3 Months [ Time Frame: 3 Months ]
   Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
3. Mean Gingival Bleeding Index (BI) at 1 Month [ Time Frame: 1 Month ]
   Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
4. Mean Gingival Bleeding Index (BI) at 3 Months [ Time Frame: 3 Months ]
   Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
5. Mean Gingival Bleeding Index (BI) at 6 Months [ Time Frame: 6 Months ]
   Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
6. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month [ Time Frame: 1 Month ]
   Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
7. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months [ Time Frame: 3 Months ]
   Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
8. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months [ Time Frame: 6 Months ]
   Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

Brazil

University of Taubate

Taubate, Sao Paulo, Brazil, 12020-270

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

University of Taubate

Investigators

• Principal Investigator: Jose Cortelli, Ph. D; Universidade de Taubate
• Study Chair: Sheila Cortelli, Ph.D; Universidade de Taubate

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT02980497 History of Changes
• Other Study ID Numbers: FCLGBP0056
• First Posted: December 2, 2016
• Last Update Posted: December 2, 2016
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

mouthrinse; plaque; gingivitis; gum bleeding

Additional relevant MeSH terms:

Gingivitis; Inflammation; Hemorrhage; Pathologic Processes; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Ethanol; Anti-Infective Agents, Local; Listerine; Thymol; Eucalyptol; Salicylates; Methyl salicylate; Menthol; Sodium Fluoride; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Cariostatic Agents; Protective Agents; Antipruritics; Dermatologic Agents; Antifungal Agents; Antitussive Agents; Respiratory System Agents; Insect Repellents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic