Oral Tissue Tolerance of a Mouthrinse

NCT01009554 | Completed Results

• 1 other identifier: UNKPLT0002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Health

Keywords

Mouthwashes

Outcome Measures

Primary Outcomes (2)

• Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment

  The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L\*, a\*, and b\* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = \[(ΔL\*)\^2 + (Δa\*)\^2 + (Δb\*)\^2\]\^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.

  8 weeks

• Oral Tissue Tolerance

  Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.

  through 8 weeks

Secondary Outcomes (62)

• Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment

  4 weeks

• Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment

  6 weeks

• Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment

  4 weeks

• Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment

  6 weeks

• Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment

  8 weeks

Study Arms (2)

Potassium Oxylate

EXPERIMENTAL

1.5% potassium oxalate sensitive mouthwash

Device: Potassium Oxylate Mouthwash

Sodium Fluoride

ACTIVE COMPARATOR

Sodium Fluoride Dentifrice

Drug: Sodium Fluoride Dentifrice

Interventions

Potassium Oxylate Mouthwash DEVICE

Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice

Also known as: Formula 11794-050

Potassium Oxylate

Sodium Fluoride Dentifrice DRUG

Brush in usual manner, twice daily, with a sodium fluoride dentifrice

Also known as: Regular Cavity Protection toothpaste

Sodium Fluoride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

TKL Reearch, Inc.

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Interventions

hydrated silica gel-based toothpaste

Results Point of Contact

• Title: Michael Lynch, DMD, PhD/Study Director
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

mlynch23@its.jnj.com

908-433-6423 USA EST

Study Officials

• Michael Lynch, DMD, PhD

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 3, 2015
• Results First Posted: July 3, 2015

Record last verified: 2015-06

Locations

US (1)