A Twelve Week Study of Supervised Mouth Rinse and Flossing
Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Sep 2018
Shorter than P25 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedFirst Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedSeptember 28, 2021
April 1, 2021
3 months
January 4, 2021
September 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
12 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
12 Weeks
Secondary Outcomes (7)
Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
4 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
4 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use
4 Weeks and 12 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use
4 Weeks and 12 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
4 Weeks and 12 Weeks
- +2 more secondary outcomes
Study Arms (4)
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
EXPERIMENTALParticipants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
EXPERIMENTALParticipants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Group 3: Flossing Performed by Dental Hygienist
EXPERIMENTALParticipants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
Group 4: Flossing under Supervision
EXPERIMENTALParticipants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
Interventions
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
Participants will brush teeth at least one minute with provided toothbrush twice daily.
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salus Research, Inc.
Fort Wayne, Indiana, 46825, United States
Related Publications (3)
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.
PMID: 12699051BACKGROUNDMarsh PD. Controlling the oral biofilm with antimicrobials. J Dent. 2010 Jun;38 Suppl 1:S11-5. doi: 10.1016/S0300-5712(10)70005-1.
PMID: 20621238BACKGROUNDSharma 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.
PMID: 12691269BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery Milleman, DDS
Salus Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 6, 2021
Study Start
September 26, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
September 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.