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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980497
• Other study ID #: FCLGBP0056
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: November 30, 2016
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Gingivitis
• Gum Inflammation
• Hemorrhage
• Inflammation
• Plaque

Intervention

Other:
• 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

Locations

Country	Name	City	State
Brazil	University of Taubate	Taubate	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide	University of Taubate

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Modified Gingival Index (MGI) at 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.	6 Months	No
Secondary	Mean Modified Gingival Index (MGI) at 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.	1 Month	No
Secondary	Mean Modified Gingival Index (MGI) at 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 Months	No
Secondary	Mean Gingival Bleeding Index (BI) at 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.	1 Month	No
Secondary	Mean Gingival Bleeding Index (BI) at 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.	3 Months	No
Secondary	Mean Gingival Bleeding Index (BI) at 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 Months	No
Secondary	Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 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.	1 Month	No
Secondary	Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 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.	3 Months	No
Secondary	Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 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.	6 Months	No