LISTERINE® Antiseptic & Floss Clinical Trial

Objective

To evaluate the efficacy of twice-daily alcohol-containing, essential oil mouthrinse (LISTERINE^® Antiseptic) and brushing, and flossing and brushing, under once-daily supervision for the prevention and reduction of plaque and gingivitis.*

*Floss is intended to remove plaque and food particles between teeth to reduce tooth decay.²

Methodology

Primary endpoints were interproximal mean Modified Gingival Index (MGI) and interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) at Week 12. Interproximal mean bleeding index (Bl) at Week 12 was a secondary endpoint.

• All subjects were supervised once daily at the clinic, Monday through Friday. Second treatment of the day, Saturdays, and Sundays at home were unsupervised and recorded in diaries.
• For all oral examinations, subjects refrained from oral hygiene for 8-18 hours and did not eat for >4 hours before the visit.

SUBJECTS (N=156) WERE RANDOMIZED INTO 4 GROUPS:

Inclusion criteria: aged >18 years; good general and oral health; no known allergies to commercial dental products; >20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; >10 bleeding sites based on the Bl; and absence of: fixed or removable orthodontic appliance or removable partial dentures, significant oral soft tissue pathology excluding plaque-induced gingivitis, and advanced periodontitis based on a clinical examination and discretion of the investigator/dental examiner.

Exclusion criteria: dental prophylaxis within 1 month prior to the Baseline visit; need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy within 1 month prior to Baseline; use of oral care products containing chemotherapeutic anti-plaque/anti-gingivitis products within 2 weeks prior to Baseline; use of smokeless tobacco; and any other medical or psychiatric condition that would make the volunteer inappropriate for the study in the judgement of the Investigator.

Results

At Week 12, compared with brushing + negative-control mouthrinse, only brushing + LISTERINE® Antiseptic provided statistically significant plaque reduction; and brushing + LISTERINE® Antiseptic, brushing + flossing by hygienist, and brushing + flossing under supervision groups provided statistically significant gingivitis and bleeding reduction.

• Compared with brushing + negative-control mouthrinse, interproximal and whole mouth plaque were significantly reduced for the brushing + LISTERINE® Antiseptic group, but not for the brushing + flossing by hygienist or brushing + flossing under supervision groups, at Week 12

LISTERINE^® Antiseptic Significantly Reduced Plaque and Gingivitis: 

^‡Flossing by dental hygienist. Sustained plaque reduction after a dental prophylaxis.

NOTE: Flossing effectively removes imbedded food particles and biofilm between the teeth, helping improve the health of patients' gums and offering a useful tool in daily oral hygiene. Together, flossing, brushing, and rinsing with LISTERINE® Antiseptic on a daily basis provides a comprehensive approach to oral care and an approach to cleaning that reaches nearly 100% of the mouth.^2,3

• Compared with Brushing + negative-control mouthrinse, interproximal and whole-mouth gingivitis were significantly reduced for the Brushing + LISTERINE® Antiseptic group, as well as for the Brushing + Flossing by Hygienist and Brushing + Flossing Under Supervision groups
  
  
• Compared with Brushing + negative-control mouth rise, interproximal bleeding index was significantly reduced in the Brushing + LISTERINE® Antiseptic, Brushing + Flossing by Hygienist, and Brushing + Flossing Under Supervision groups
  
  
• To measure bleeding index, a periodontal probe with a 0.5 mm tip was inserted into the gingival crevice and swept about the tooth at approximately a 60-degree angle. Each of four gingival areas (disto-buccal, mid-buccal, mid-lingual, mesio-lingual) was assessed after about 30 seconds. (0=no bleeding; 1 = bleeding after 30 seconds; 2=immediate bleeding.)

Conclusions

• LISTERINE® Antiseptic yielded larger reductions compared to brushing alone in plaque (TPI) and gingivitis (MGI) than hygienist-performed or hygienist-supervised flossing at Week 12
• LISTERINE® Antiseptic, hygienist-performed flossing, and hygienist-supervised flossing all statistically significantly reduced interproximal bleeding at Week 12 compared to negative-control mouthrinse
• Adding LISTERINE® Antiseptic to an oral care routine reduced supragingival plaque more effectively than flossing by a dental hygienist
  • Dental professionals may use these data to recommend the most effective oral care routines to their patients depending on their needs

References: 1. Bosma ML, McGuire JA, Sunkara A, Sullivan P, Yoder A, Milleman J, Milleman K. Efficacy of Flossing and Mouthrinsing Regimens on Plaque and Gingivitis: A randomized clinical trial. J Dent Hyg. June 2022; 96(3), 8-20 2. Flossing & Brushing. CDA website, https://www.cda-adc.ca/en/oral_health/cfyt/dental_care/flossing_brushing... Last reviewed: September 21, 2021. Accessed January 3, 2022. 3. Kerr WJS, Kelly J, Geddes DAM. The areas of various surfaces in the human mouth from nine years to adulthood. J Dent Res. 1991;70:1528-1530.