Clinical trial NCT01009554: Oral Tissue Tolerance of a Mouthrinse
Official title: Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Health
Keywords: Mouthwashes
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.

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.

Primary outcomes:
measure: Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
timeFrame: 8 weeks
measure: Oral Tissue Tolerance
timeFrame: through 8 weeks
Secondary outcomes:
measure: Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
timeFrame: 4 weeks
measure: Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
timeFrame: 6 weeks
measure: Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
timeFrame: 4 weeks
measure: Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
timeFrame: 6 weeks
measure: Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
timeFrame: 8 weeks
measure: Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
timeFrame: 4 weeks
measure: Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
timeFrame: 6 weeks
measure: Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
timeFrame: 8 weeks
measure: Mean Stain Score Over All Tooth Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score Over All Tooth Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score Over All Tooth Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity Over All Tooth Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity Over All Tooth Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity Over All Tooth Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area Over All Tooth Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area Over All Tooth Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area Over All Tooth Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Score for Gingival Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score for Gingival Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score for Gingival Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity for Gingival Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity for Gingival Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity for Gingival Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area for Gingival Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area for Gingival Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area for Gingival Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Score for Body Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score for Body Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score for Body Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity for Body Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity for Body Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity for Body Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area for Body Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area for Body Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area for Body Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Score for Facial Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score for Facial Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score for Facial Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity for Facial Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity for Facial Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity for Facial Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area for Facial Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area for Facial Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area for Facial Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Score for Lingual Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Score for Lingual Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Score for Lingual Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Intensity for Lingual Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Intensity for Lingual Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Intensity for Lingual Sites at 8 Weeks
timeFrame: 8 weeks
measure: Mean Stain Area for Lingual Sites at 4 Weeks
timeFrame: 4 weeks
measure: Mean Stain Area for Lingual Sites at 6 Weeks
timeFrame: 6 weeks
measure: Mean Stain Area for Lingual Sites at 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Reearch, Inc.
state: New Jersey
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Michael Lynch, DMD, PhD
role: STUDY_DIRECTOR
References: