Clinical trial NCT04696536: A Twelve Week Study of Supervised Mouth Rinse and Flossing
Official title: Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.


Eligibility criteria: Inclusion criteria:

* Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
* Able to attend once daily session during weekdays for flossing and rinsing occurring on site
* 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
* Able to read and understand the local language (participants capable of reading the documents)
* Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)
* 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
* A minimum of 10 bleeding sites based on the BI
* Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner

Exclusion criteria:

* History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
* Dental prophylaxis within four weeks prior to Screening/Baseline visit
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
* Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline

Primary outcomes:
measure: Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
timeFrame: 12 Weeks
measure: Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
timeFrame: 12 Weeks
Secondary outcomes:
measure: Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
timeFrame: 4 Weeks
measure: Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
timeFrame: 4 Weeks
measure: Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use
timeFrame: 4 Weeks and 12 Weeks
measure: Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use
timeFrame: 4 Weeks and 12 Weeks
measure: Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
timeFrame: 4 Weeks and 12 Weeks
measure: Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use
timeFrame: 4 Weeks and 12 Weeks
measure: Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks
timeFrame: 4 Weeks and 12 Weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: Salus Research, Inc.
name: Jeffery Milleman, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
citation: Marsh PD. Controlling the oral biofilm with antimicrobials. J Dent. 2010 Jun;38 Suppl 1:S11-5. doi: 10.1016/S0300-5712(10)70005-1.
citation: Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.