N/A
N=96
Oral Tissue Tolerance of a Mouthrinse
Dental Health
Bottom Line
View on ClinicalTrials.gov: NCT01009554 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment — 0.909; 1.035 units on a scale — p=0.168
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium Oxylate Mouthwash (Device); Sodium Fluoride Dentifrice (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment |
0.909; 1.035 | 0.168 |
| PRIMARY Oral Tissue Tolerance |
2.1; 0.0; 2.1; 0.0 | — |
| SECONDARY Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment |
0.875; 0.882 | 0.928 |
| SECONDARY Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment |
0.805; 1.040 | 0.002 sig |
| SECONDARY Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment |
0.013; 0.054 | 0.741 |
| SECONDARY Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment |
0.071; -0.090 | 0.249 |
| SECONDARY Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment |
0.158; -0.043 | 0.154 |
| SECONDARY Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment |
0.077; -0.117 | 0.011 sig |
| SECONDARY Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment |
0.123; -0.212 | <0.001 sig |
| SECONDARY Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment |
0.107; -0.107 | 0.025 sig |
| SECONDARY Mean Stain Score Over All Tooth Sites at 4 Weeks |
0.329; 0.386 | 0.319 |
| SECONDARY Mean Stain Score Over All Tooth Sites at 6 Weeks |
0.349; 0.621 | <0.001 sig |
| SECONDARY Mean Stain Score Over All Tooth Sites at 8 Weeks |
0.394; 0.791 | <0.001 sig |
| SECONDARY Mean Stain Intensity Over All Tooth Sites at 4 Weeks |
0.154; 0.184 | 0.270 |
| SECONDARY Mean Stain Intensity Over All Tooth Sites at 6 Weeks |
0.164; 0.302 | <0.001 sig |
| SECONDARY Mean Stain Intensity Over All Tooth Sites at 8 Weeks |
0.181; 0.375 | <0.001 sig |
| SECONDARY Mean Stain Area Over All Tooth Sites at 4 Weeks |
0.162; 0.196 | 0.217 |
| SECONDARY Mean Stain Area Over All Tooth Sites at 6 Weeks |
0.166; 0.303 | <0.001 sig |
| SECONDARY Mean Stain Area Over All Tooth Sites at 8 Weeks |
0.188; 0.383 | <0.001 sig |
| SECONDARY Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks |
0.408; 0.463 | 0.444 |
| SECONDARY Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks |
0.427; 0.776 | <0.001 sig |
| SECONDARY Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks |
0.451; 0.994 | <0.001 sig |
| SECONDARY Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks |
0.192; 0.224 | 0.361 |
| SECONDARY Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks |
0.205; 0.379 | <0.001 sig |
| SECONDARY Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks |
0.210; 0.475 | <0.001 sig |
| SECONDARY Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks |
0.202; 0.236 | 0.331 |
| SECONDARY Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks |
0.206; 0.383 | <0.001 sig |
| SECONDARY Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks |
0.218; 0.483 | <0.001 sig |
| SECONDARY Mean Stain Score for Gingival Sites at 4 Weeks |
0.383; 0.521 | 0.060 |
| SECONDARY Mean Stain Score for Gingival Sites at 6 Weeks |
0.395; 0.732 | <0.001 sig |
| SECONDARY Mean Stain Score for Gingival Sites at 8 Weeks |
0.526; 0.920 | <0.001 sig |
| SECONDARY Mean Stain Intensity for Gingival Sites at 4 Weeks |
0.180; 0.252 | 0.045 sig |
| SECONDARY Mean Stain Intensity for Gingival Sites at 6 Weeks |
0.180; 0.358 | <0.001 sig |
| SECONDARY Mean Stain Intensity for Gingival Sites at 8 Weeks |
0.241; 0.438 | <0.001 sig |
| SECONDARY Mean Stain Area for Gingival Sites at 4 Weeks |
0.186; 0.263 | 0.034 sig |
| SECONDARY Mean Stain Area for Gingival Sites at 6 Weeks |
0.184; 0.352 | <0.001 sig |
| SECONDARY Mean Stain Area for Gingival Sites at 8 Weeks |
0.250; 0.444 | <0.001 sig |
| SECONDARY Mean Stain Score for Body Sites at 4 Weeks |
0.132; 0.112 | 0.524 |
| SECONDARY Mean Stain Score for Body Sites at 6 Weeks |
0.160; 0.215 | 0.172 |
| SECONDARY Mean Stain Score for Body Sites at 8 Weeks |
0.143; 0.258 | 0.010 sig |
| SECONDARY Mean Stain Intensity for Body Sites at 4 Weeks |
0.058; 0.045 | 0.348 |
| SECONDARY Mean Stain Intensity for Body Sites at 6 Weeks |
0.075; 0.100 | 0.185 |
| SECONDARY Mean Stain Intensity for Body Sites at 8 Weeks |
0.063; 0.112 | 0.014 sig |
| SECONDARY Mean Stain Area for Body Sites at 4 Weeks |
0.064; 0.056 | 0.623 |
| SECONDARY Mean Stain Area for Body Sites at 6 Weeks |
0.076; 0.100 | 0.192 |
| SECONDARY Mean Stain Area for Body Sites at 8 Weeks |
0.067; 0.124 | 0.009 sig |
| SECONDARY Mean Stain Score for Facial Sites at 4 Weeks |
0.063; 0.058 | 0.893 |
| SECONDARY Mean Stain Score for Facial Sites at 6 Weeks |
0.118; 0.140 | 0.655 |
| SECONDARY Mean Stain Score for Facial Sites at 8 Weeks |
0.097; 0.319 | 0.002 sig |
| SECONDARY Mean Stain Intensity for Facial Sites at 4 Weeks |
0.027; 0.025 | 0.914 |
| SECONDARY Mean Stain Intensity for Facial Sites at 6 Weeks |
0.054; 0.065 | 0.646 |
| SECONDARY Mean Stain Intensity for Facial Sites at 8 Weeks |
0.042; 0.144 | 0.001 sig |
| SECONDARY Mean Stain Area for Facial Sites at 4 Weeks |
0.032; 0.033 | 0.930 |
| SECONDARY Mean Stain Area for Facial Sites at 6 Weeks |
0.059; 0.075 | 0.486 |
| SECONDARY Mean Stain Area for Facial Sites at 8 Weeks |
0.047; 0.160 | 0.001 sig |
| SECONDARY Mean Stain Score for Lingual Sites at 4 Weeks |
0.596; 0.716 | 0.237 |
| SECONDARY Mean Stain Score for Lingual Sites at 6 Weeks |
0.586; 1.106 | <0.001 sig |
| SECONDARY Mean Stain Score for Lingual Sites at 8 Weeks |
0.677; 1.244 | <0.001 sig |
| SECONDARY Mean Stain Intensity for Lingual Sites at 4 Weeks |
0.282; 0.344 | 0.210 |
| SECONDARY Mean Stain Intensity for Lingual Sites at 6 Weeks |
0.279; 0.541 | <0.001 sig |
| SECONDARY Mean Stain Intensity for Lingual Sites at 8 Weeks |
0.314; 0.596 | <0.001 sig |
| SECONDARY Mean Stain Area for Lingual Sites at 4 Weeks |
0.293; 0.359 | 0.187 |
| SECONDARY Mean Stain Area for Lingual Sites at 6 Weeks |
0.277; 0.533 | <0.001 sig |
| SECONDARY Mean Stain Area for Lingual Sites at 8 Weeks |
0.325; 0.598 | <0.001 sig |
Summary
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.
Eligibility Criteria
Inclusion Criteria
- Males and females at least 18 years of age and in good general and oral health.
- Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study.
- Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study.
- Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation.
- A minimum of 16 natural teeth, including at least 10 of the 12 anterior teeth (#6-11, #22-27, however, #7-10 must be present), with scorable facial and lingual surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
- Classic Vita® Shade minimum value of A2 or darker on at least 2 of the 4 maxillary anterior teeth (#7-10).
- Absence of abnormal or severely fissured tongue, geographic tongue, tongue piercing or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Absence of neglected dental health (i.e. gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systemically-related gingival enlargement, tissue damage due to ill-fitting appliances or restoration, or extreme crowding or overlapping of teeth
Exclusion Criteria
- Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
- Prior participation in any oral hygiene or product clinical study within the previous 30 days.
- Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine).
- Restorations on 10% or more of the facial surfaces of the maxillary anterior incisor teeth.
- Dental fluorosis, hypoplasia, restorations, tetracycline stains, or other enamel surface irregularities that may interfere with evaluation of the selected teeth.
- Visual evidence of Moderate/advanced periodontitis (ADA Type III, IV). Orthodontic bands, appliances, bridges, numerous crowns, removable orthodontic appliances or partial dentures.
- 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).
- Regular use of whitening products within 1 week prior to Screening/Baseline. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for the entry into this trial.
Data sourced from ClinicalTrials.gov (NCT01009554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.