Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe

NCT03478644 | Completed Results FDA Device

• 1 other identifier: 203115
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.

Conditions

Denture Cleansers

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use

  Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).

  up to 14 days

• Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use

  Proportion of participants experiencing or reporting TE oral AEs on or before 7 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).

  up to 7 days

Secondary Outcomes (2)

• Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use

  Day 7, Day 14

• Number of Participants Responses for Consumer Acceptability Questionnaire Score

  Day 7

Study Arms (2)

Experimental Denture Wipe

EXPERIMENTAL

Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.

Device: Experimental Denture Wipe

Tap Water

PLACEBO COMPARATOR

Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.

Other: Tap Water

Interventions

Experimental Denture Wipe DEVICE

Participants were instructed to use the experimental wipe to clean their dentures, external to their mouth, up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. Participants were instructed to use one wipe per denture.

Experimental Denture Wipe

Tap Water OTHER

Participants were instructed to use running tap water to clean their dentures up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days.

Tap Water

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demonstrated understanding of the study procedures, restrictions and was willing to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the informed consent form.
• Understood and was willing, able and comply with all study procedures and restrictions.
• Participant was in good general and mental health with, in the opinion of the investigator or medically qualified designee - (a) no clinically significant and relevant abnormalities of medical or physical history; (b) absence of any condition that impacted on the participant's safety or well-being or affected the individual's ability to understand and follow study procedures.
• Denture Requirements, fully or partially edentulous: (a) Phase 1 eligible participants had a full upper denture and may Have a full or partial lower denture or no lower Denture; (b) Phase 2 eligible subjects will have at least one full or partial denture; (c) Dentures considered in good condition according to the investigator or dental examiner, with no damage according to assessment criteria; (d) Participants with a peanut particle migration rating greater than zero on the upper denture only for participants screened for food removal testing.

You may not qualify if:

• Women who were known to be pregnant or who were intending to become pregnant over the duration of the study.
• Women who were breast-feeding.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Known allergy to any nuts or peanuts. History of allergic reactions or intense feelings of discomfort to topically used products: cosmetics or drugs.
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, except for participants who were enrolled on GSKCH study 205915 who might enrolled onto this study 7 days after their completion of 205915. Previous participation in this study.
• Recent history (within the last one year) of alcohol or other substance abuse.
• An employee of the sponsor or the study site or members of their immediate family.
• Denture adhesive users were excluded from this study.
• Participants with OST findings such as, stomatitis, open sores, lesions, redness or swelling were excluded.
• Other Conditions because of participants were excluded are as follows: History of swallowing or choking difficulties; participants unwilling to refrain from using their existing denture cleansing routine for the duration of the study; taking or have taken a bisphosphonate drug for treatment of osteoporosis; skin marks in the experimental area which may interfere with the evaluation of potential skin reactions; active skin diseases (local and/or disseminated) that may interfere with the study results; participants with immunodeficiencies, intense sunlight exposure or tanning session within 15 days before the baseline evaluation or during the study that has resulted in sunburn; body cosmetic and/or dermatological treatment until three weeks before screening or during the study; continual use of therapeutic, topical or systemic use of the following drugs: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs and corticosteroids within two weeks before the screening for chronic conditions; oral or topical treatment with vitamin A acid and/or its derivatives within one month before start of study; vaccination within three weeks before or during the study; participants with dermographism; any condition not previously mentioned that in the investigator's opinion may impair the study evaluation.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The dental examiner and dermatologist blinded for both treatment arms.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: October 10, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: October 15, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-07

Locations

US (1)