CompletedNCT05756673Updated Oct 17, 2023

A Study of Virtually Supervised Mouthwash and Interdental Brushes

A Phase 4 interventional study of Colgate Cavity Protection Toothpaste and LISTERINE ZERO Alcohol Mouthwash COOL MINT in Healthy, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 292
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to assess the relative effectiveness of oral (mouth) care regimens for the avoidance and treatment of plaque and gingivitis.

Conditions studied

Healthy

In context

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
Evidence of a personally signed and dated informed consent document indicating the participant has been informed of all pertinent aspects of the trial
Able to read and understand (participants capable of reading the documents)
Able to schedule once daily virtual session during weekdays during the first three months of the study (up to visit 3) and then three times a week for the remainder of the study for interdental brush use and rinsing in real time via a platform such as Zoom, Facetime, Google Meet, Etcetera (etc)
Adequate oral hygiene (that is, brush teeth daily and exhibit no signs or oral neglect)
Males and females in good general and oral health without any known allergy to commercial dental products or cosmetics
Evidence of being fully vaccinated for corona virus disease-2019 (COVID-19) (adults 60 years and older)
Negative pregnancy urine tests (females of childbearing potential only)
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
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
Participants should have a minimum of 20 interproximal areas where interdental brushes can be inserted
All interproximal sites must be able to accommodate an interdental brush
A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
Participants will have evidence of some gingivitis (mild to severe); there will be no minimum or maximum mean Modified Gingival Index (MGI) score for gingivitis or Turesky Modification of the Quigley Hein Plaque Index (TPI) score for plaque
No more than 3 sites having pocket depths of 5 millimeters (mm) and no sites that are greater than 5 mm in depth
Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator
Absence of advanced periodontitis based on a clinical examination at baseline and discretion of the dental examiner
Absence of dental implants, fixed or removable orthodontic appliance or removable partial dentures or other appliances which may interfere with supervised interdental brushing

Exclusion criteria

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; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients or other ingredients in the products
Dental prophylaxis within four weeks prior to baseline visit
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Use of antibiotics, 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 mouthwashes and toothpastes within four weeks prior to baseline
Regular consumption of probiotic drinks/supplements within one week prior to screening/baseline;
Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results)
Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage
Suspected alcohol or substance abuse (example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
Significant unstable or uncontrolled medical condition which may interfere with a participant's participation in the study, including cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state (weakened immune system) from solid organ transplant, serious heart conditions, (such as heart failure, coronary artery disease, or cardiomyopathies) sickle cell disease, Type 1 or 2 diabetes mellitus)
Participation in any clinical trial within 30 days of baseline visit
Participants who were previously screened and ineligible or were randomized to receive investigational product
Participants who are related to those persons involved directly or indirectly with the conduct of this study (that is, principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each)
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study
COVID-19 restrictions: Participants who fail to meet the criteria of the site's screening consent for preventing Infection in the site's COVID-19 consent form

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 292 participants (actual)

Study arms

Other
Brush Only
Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Drug: Colgate Cavity Protection Toothpaste
Experimental
Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE ZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Drug: Colgate Cavity Protection Toothpaste · Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT
Experimental
Interdental Brush/Brush
Participants will use their interdental brush according to their personalized "mouth map", rinse with water then brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Drug: Colgate Cavity Protection Toothpaste · Device: TePe Original Interdental Brush
Experimental
Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE COOL MINT Antiseptic Mouthwash under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Drug: Colgate Cavity Protection Toothpaste · Drug: LISTERINE COOL MINT Antiseptic Mouthwash · Device: TePe Original Interdental Brush
Experimental
Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINEZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Drug: Colgate Cavity Protection Toothpaste · Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT · Device: TePe Original Interdental Brush

Interventions

DrugColgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
DrugLISTERINE ZERO Alcohol Mouthwash COOL MINT
Participants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily.
DrugLISTERINE COOL MINT Antiseptic Mouthwash
Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.
DeviceTePe Original Interdental Brush
Participants will use Interdental Brush according to their personalized mouth map once daily in the morning.

What researchers measure

Primary outcomes

Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use
Interproximal mean TPI after 24 weeks of product use will be reported. Plaque area will be scored by the Turesky Modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (no plaque); 1 (separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (thin, up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin); 3 (band of plaque wider than 1mm but less than1/3 of the surface); 4 (plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (plaque covering 2/3 or more of the surface).
Time frame: After 24 weeks of product use
Interproximal Mean Modified Gingival Index (MGI) After 24 Weeks of Product Use
Interproximal mean MGI after 24 weeks of product use will be reported. Gingivitis will be assessed by the MGI 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).
Time frame: After 24 weeks of product use

Secondary outcomes

Interproximal Mean TPI after 4 and 12 Weeks
Interproximal mean TPI after 4 and 12 weeks will be reported. Plaque area will be scored by the Turesky Modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (no plaque); 1 (separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (thin, up to 1 mm), continuous band of plaque at the gingival margin); 3 (band of plaque wider than 1mm but less than1/3 of the surface); 4 (plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (plaque covering 2/3 or more of the surface).
Time frame: After 4 and 12 weeks
Interproximal Mean MGI after 4 and 12 Weeks
Interproximal mean MGI after 4 and 12 weeks will be reported. Gingivitis will be assessed by the MGI 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).
Time frame: After 4 and 12 weeks
Interproximal Mean Expanded Bleeding Index (EBI) After 4, 12 and 24 Weeks
Interproximal mean EBI after 4, 12 and 24 weeks will be reported. Bleeding will be assessed according to the EBI, 168 sites. 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 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).
Time frame: After 4, 12 and 24 weeks
Interproximal Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks
Interproximal percent bleeding sites based on EBI after 4, 12 and 24 weeks will be reported. Bleeding will be assessed according to the EBI, 168 Sites. 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 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean TPI After 4, 12 and 24 Weeks
Whole mouth mean TPI after 4, 12 and 24 weeks will be reported. Plaque area will be scored by the Turesky Modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (no plaque); 1 (separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (thin, up to 1 mm), continuous band of plaque at the gingival margin); 3 (band of plaque wider than 1mm but less than1/3 of the surface); 4 (plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (plaque covering 2/3 or more of the surface).
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean MGI After 4, 12 and 24 Weeks
Whole mouth mean MGI after 4, 12 and 24 weeks will be reported. Gingivitis will be assessed by the MGI 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).
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean EBI After 4, 12 and 24 Weeks
Whole mouth mean EBI after 4, 12 and 24 weeks will be reported. Bleeding will be assessed according to the EBI, 168 Sites. 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 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).
Time frame: After 4, 12 and 24 weeks
Whole Mouth Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks
Whole mouth percent bleeding sites based on EBI after 4, 12 and 24 weeks will be reported. Bleeding will be assessed according to the EBI, 168 Sites. 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 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).
Time frame: After 4, 12 and 24 weeks
Marginal Mean TPI After 4, 12 and 24 Weeks
Marginal mean TPI after 4, 12 and 24 weeks will be reported. Plaque area will be scored by the Turesky Modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (no plaque); 1 (separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (thin, up to 1 mm), continuous band of plaque at the gingival margin); 3 (band of plaque wider than 1mm but less than1/3 of the surface); 4 (plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (plaque covering 2/3 or more of the surface).
Time frame: After 4, 12 and 24 weeks
Marginal Mean MGI After 4, 12 and 24 Weeks
Marginal mean MGI after 4, 12 and 24 weeks will be reported. Gingivitis will be assessed by the MGI 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).
Time frame: After 4, 12 and 24 weeks
Marginal Mean EBI After 4, 12 and 24 Weeks
Marginal mean EBI after 4, 12 and 24 weeks will be reported. Bleeding will be assessed according to the EBI, 168 Sites. 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 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).
Time frame: After 4, 12 and 24 weeks
Whole Mouth and Interproximal Mean Pocket Depth After 12 and 24 Weeks
Whole mouth and interproximal mean pocket depth after 12 and 24 weeks will be reported.
Time frame: After 12 and 24 weeks
Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 and 24 Weeks
Whole mouth and interproximal mean bleeding upon probing pocket depths after 12 and 24 weeks will be reported. At each of the 6 sites (disto-facial, mid facial, mesio-facial, mesio-lingual, mid-lingual and disto-lingual), bleeding will be observed and scores as: 0=no bleeding and 1=bleeding.
Time frame: After 12 and 24 weeks
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI)
Whole-mouth mean RMNPI will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored from 0 to 1, where 0=no plaque and 1=plaque present in the measured segment of the tooth.
Time frame: Up to 24 weeks
Interproximal Mean RMNPI (Sites D and F)
Interproximal mean RMNPI (sites D and F) will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored from 0 to 1, where 0=no plaque and 1=plaque present in the measured segment of the tooth.
Time frame: Up to 24 weeks
Expanded Interproximal Mean RMNPI (Sites D, F, A, and C)
Expanded interproximal mean RMNPI (Sites D, F, A, and C) will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored 0 to 1 where 0=no plaque and 1=plaque present in the measured segment of the tooth.
Time frame: Up to 24 weeks
Observed Bacterial Species Richness As Assessed by Next Generation Deoxyribonucleic Acid (DNA) Sequencing
Observed bacterial species richness is measured from collected plaque specimens using Next-Generation DNA sequencing and counting the number of distinct bacterial species. Lower numbers represent scarcity of bacterial types while higher numbers represent large biodiversity of bacterial types detected in collected specimens.
Time frame: At baseline, Weeks 4, 12 and 24
Shannon-Weaver Diversity Index
The Shannon-Weaver diversity index will be reported for supragingival plaque assessment.
Time frame: At baseline, Weeks 4, 12 and 24
Total Species Microbial Load
Total species microbial load will be reported for supragingival plaque assessment.
Time frame: At baseline, Weeks 4, 12 and 24
Categorical Species Microbial Load
Categorical species microbial load will be reported for supragingival plaque assessment.
Time frame: At baseline, Weeks 4, 12 and 24
Individual Species Microbial Load
Individual species microbial load will be reported for supragingival plaque assessment.
Time frame: At baseline, Weeks 4, 12 and 24
Sample Clustering Analysis for Composition Change
Sample clustering analysis for composition change will be reported for supragingival plaque assessment.
Time frame: At baseline, Weeks 4, 12 and 24
Number of Total Bacteria and Select Species of Interest Expressed in Log10
Quantification of live total bacteria and select species of interest in supra and sub-gingival plaque using viability quantitative polymerase chain reaction (qPCR) will be reported in Log10 bacterial cell number.
Time frame: At Baseline and Week 24

Study locations

1 site

Salus Research, Inc.
Fort Wayne, Indiana 46825, United States

References and documents

Publications

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. Erratum In: J Am Dent Assoc. 2003 May;134(5):558. PubMed 12699051 ↗
Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217. PubMed 15127875 ↗
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. PubMed 12691269 ↗
Milleman K, Milleman J, Bosma ML, McGuire JA, Sunkara A, DelSasso A, York T, Cecil AM. Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens. J Dent Hyg. 2022 Jun;96(3):35-45. PubMed 35654566 ↗
Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available. PubMed 3485495 ↗
Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x. PubMed 7806674 ↗
Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x. PubMed 2524573 ↗
CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available. PubMed 13809868 ↗
Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12. PubMed 1306676 ↗
Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. PubMed 5264376 ↗
11Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.

Individual participant data

Plan to share: Yes — 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05756673
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Responsible party: Sponsor
First posted: Mar 6, 2023
Start date: Feb 9, 2023
Primary completion: Oct 3, 2023
Completion: Oct 3, 2023
Last update: Oct 17, 2023

Study contacts

Jeffery Milleman, DDS

principal investigator · Salus Research, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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