A Twelve Week Study of Supervised Mouth Rinse and Flossing

Healthy Clinical Trial

Official title:

Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696536
• Other study ID #: CCSORC000708
• Secondary ID: CCSORC000708
• Status: Completed
• Phase: Phase 4
• Start date: September 26, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: April 2021
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
• American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
• 5% Hydroalcohol Mouth Rinse
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
• REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
• Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.

Locations

Country	Name	City	State
United States	Salus Research, Inc.	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: J Am Dent Assoc. 2003 May;134(5):558. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Interproximal Mean Turesky Plaque Index (TPI) Score After 4 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.	4 Weeks
Secondary	Interproximal Mean Modified Gingival Index (MGI) Score After 4 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.	4 Weeks
Secondary	Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 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.	4 Weeks and 12 Weeks
Secondary	Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 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.	4 Weeks and 12 Weeks
Secondary	Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use	Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.	4 Weeks and 12 Weeks
Secondary	Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use	Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.	4 Weeks and 12 Weeks
Secondary	Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks	Interproximal Plaque area will be assessed using the PMI on the facial and lingual surfaces. Distal proximal and mesial proximal will be assessed on all teeth including the distal of the second molar using the following scoring system: 0- No plaque; 1 - Separate flecks of plaque covering less than 1/3 of the area; 2 - Discrete areas or bands of plaque covering less than 1/3 of the area; 3 - Plaque covering 1/3 of the area; 4 - Plaque covering more than 1/3 but less than 2/3 of the area; 5 - Plaque covering 2/3 or more of the area.	4 Weeks and 12 Weeks

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