Clinical trial NCT02980497: Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study
Official title: Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Gingivitis
Gum Inflammation
Bleeding
Keywords: mouthrinse
plaque
gingivitis
gum bleeding
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: University of Taubate
First posted: 2016-12-02
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Mean Modified Gingival Index (MGI) at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Mean Modified Gingival Index (MGI) at 1 Month
timeFrame: 1 Month
measure: Mean Modified Gingival Index (MGI) at 3 Months
timeFrame: 3 Months
measure: Mean Gingival Bleeding Index (BI) at 1 Month
timeFrame: 1 Month
measure: Mean Gingival Bleeding Index (BI) at 3 Months
timeFrame: 3 Months
measure: Mean Gingival Bleeding Index (BI) at 6 Months
timeFrame: 6 Months
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month
timeFrame: 1 Month
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months
timeFrame: 3 Months
measure: Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months
timeFrame: 6 Months
Other outcomes:
Locations:
city: Taubate
country: Brazil
facility: University of Taubate
state: Sao Paulo
Study officials:
affiliation: Universidade de Taubate
name: Jose Cortelli, Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade de Taubate
name: Sheila Cortelli, Ph.D
role: STUDY_CHAIR
References:
citation: 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.