Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478644
Recruitment Status : Completed
First Posted : March 27, 2018
Results First Posted : August 31, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Device Feasibility
Condition Denture Cleansers
Interventions Device: Experimental Denture Wipe
Other: Tap Water
Enrollment 152
Recruitment Details All participants were recruited at one center in the United States.
Pre-assignment Details A total of 155 participants were screened, of which first 31 eligible participants with complete upper dentures were included in Phase 1 (food removal testing). Out of 155 participants, 152 were randomized in Phase 2 (oral soft tissue and dermal assessment). 3 participants were not randomized as 2 were screened failure and 1 withdrew from study.
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily. All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
Period Title: Phase 1
Started 31 [1] 0
Completed 31 [1] 0
Not Completed 0 0
[1]
In Phase 1, only the wipe treatment was administered to eligible participants.
Period Title: Phase 2
Started 76 76
Completed 73 75
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             2             1
Lost to Follow-up             1             0
Arm/Group Title Experimental Denture Wipe Water Rinse Total
Hide Arm/Group Description All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily. All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily. Total of all reporting groups
Overall Number of Baseline Participants 76 76 152
Hide Baseline Analysis Population Description
Baseline assessment was performed on safety population, which included all participants who were randomized and received treatment at least once during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 76 participants 152 participants
60.99  (12.702) 61.03  (12.622) 61.01  (12.620)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 76 participants 152 participants
Female
57
  75.0%
48
  63.2%
105
  69.1%
Male
19
  25.0%
28
  36.8%
47
  30.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 76 participants 152 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.3%
1
   0.7%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.7%
Black or African American
10
  13.2%
8
  10.5%
18
  11.8%
White
64
  84.2%
67
  88.2%
131
  86.2%
More than one race
1
   1.3%
0
   0.0%
1
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use
Hide Description 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).
Time Frame up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on safety population which included all the participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description:
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
Overall Number of Participants Analyzed 76 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.039
(0.01 to 0.11)
0.013
(0.00 to 0.07)
2.Primary Outcome
Title Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use
Hide Description 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).
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description:
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
Overall Number of Participants Analyzed 76 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.013
(0.00 to 0.07)
0.000
(0.00 to 0.05)
3.Secondary Outcome
Title Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use
Hide Description Dermal assessment performed by a suitably qualified dermatologist on the front and back of the participant’s dominant hand (hand with which participant used to hold the wipe during use) using skin irritation score that range from 0-4 as follows: 0 = no apparent cutaneous involvement, 0.5= equivocal reaction, 1= slight erythema with or without oedema, 2= moderate erythema, oedema with or without papules, 3= severe erythema, oedema with or without papules, 4= severe erythema, oedema with vesicles or blisters. Any site where skin irritation was scored ≥2, was visually assessed and reported.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description:
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
Overall Number of Participants Analyzed 76 76
Measure Type: Number
Unit of Measure: Proportion of participants
At Day 7 0 0
At Day 14 0 0
4.Secondary Outcome
Title Number of Participants Responses for Consumer Acceptability Questionnaire Score
Hide Description All the participants supplied with a consumer acceptability questionnaire (Question [Q] 1 to 4) to complete immediately before & after their first use of treatment at home after eating a meal. The number of participants with individual score was reported. After eating & before cleaning denture: Q1= how fresh does denture feel?, Q2= how clean does denture feel?; Look in the mirror and smile, now answer the following questions: Q3= after eating & before cleaning, how clean does denture/smile look ?, Q4= after removing & cleaning denture, how fresh does denture feel?, Q5= after removing & cleaning denture, run your tongue over denture teeth, how clean does denture feel?, Q6= after removing & cleaning denture, how clean does denture/smile look?, Q7= after removing & cleaning denture, how satisfied are you with amount of debris removed? All questions were scored as follows for respective parameter(fresh/clean/satisfied): 0=Not at all, 1=slightly, 2=moderately, 3=very, 4=extremely.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description:
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
Overall Number of Participants Analyzed 76 76
Measure Type: Count of Participants
Unit of Measure: Participants
Q1: Score 0 - Not fresh at all
20
  26.3%
18
  23.7%
Q1: Score 1 - Slightly fresh
16
  21.1%
26
  34.2%
Q1: Score 2 - Moderately fresh
18
  23.7%
17
  22.4%
Q1: Score 3 - Very fresh
14
  18.4%
10
  13.2%
Q1: Score 4 - Extremely fresh
8
  10.5%
5
   6.6%
Q2: Score 0 - Not clean at all
12
  15.8%
12
  15.8%
Q2: Score 1 - Slightly clean
12
  15.8%
23
  30.3%
Q2: Score 2 - Moderately clean
26
  34.2%
21
  27.6%
Q2: Score 3 - Very clean
15
  19.7%
14
  18.4%
Q2: Score 4 - Extremely clean
11
  14.5%
6
   7.9%
Q3: Score 0 - Not clean at all
5
   6.6%
1
   1.3%
Q3: Score 1 - Slightly clean
15
  19.7%
15
  19.7%
Q3: Score 2 - Moderately clean
23
  30.3%
31
  40.8%
Q3: Score 3 - Very clean
23
  30.3%
21
  27.6%
Q3: Score 4 - Extremely clean
10
  13.2%
8
  10.5%
Q4: Score 0 - Not fresh at all
0
   0.0%
0
   0.0%
Q4: Score 1 - Slightly fresh
0
   0.0%
3
   3.9%
Q4: Score 2 - Moderately fresh
11
  14.5%
22
  28.9%
Q4: Score 3 - Very fresh
32
  42.1%
31
  40.8%
Q4: Score 4 - Extremely fresh
33
  43.4%
20
  26.3%
Q5: Score 0 - Not clean at all
0
   0.0%
1
   1.3%
Q5: Score 1 - Slightly clean
1
   1.3%
0
   0.0%
Q5: Score 2 - Moderately clean
9
  11.8%
18
  23.7%
Q5: Score 3 - Very clean
32
  42.1%
37
  48.7%
Q5: Score 4 - Extremely clean
34
  44.7%
20
  26.3%
Q6: Score 0 - Not clean at all
0
   0.0%
0
   0.0%
Q6: Score 1 - Slightly clean
1
   1.3%
1
   1.3%
Q6: Score 2 - Moderately clean
10
  13.2%
18
  23.7%
Q6: Score 3 - Very clean
33
  43.4%
37
  48.7%
Q6: Score 4 - Extremely clean
32
  42.1%
20
  26.3%
Q7: Score 0 - Not satisfied at all
0
   0.0%
0
   0.0%
Q7: Score 1 - Slightly satisfied
0
   0.0%
0
   0.0%
Q7: Score 2 - Moderately satisfied
9
  11.8%
21
  27.6%
Q7: Score 3 - Very satisfied
40
  52.6%
36
  47.4%
Q7: Score 4 - Extremely satisfied
27
  35.5%
19
  25.0%
Time Frame Approximately 17 days (from Screening Visit to Visit 3)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Denture Wipe Water Rinse
Hide Arm/Group Description Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily. Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
All-Cause Mortality
Experimental Denture Wipe Water Rinse
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)      0/76 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Denture Wipe Water Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/76 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Experimental Denture Wipe Water Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/76 (3.95%)      1/76 (1.32%)    
Gastrointestinal disorders     
Tongue coated   0/76 (0.00%)  0 1/76 (1.32%)  1
Injury, poisoning and procedural complications     
Mouth Injury   2/76 (2.63%)  2 0/76 (0.00%)  0
Lip Injury   1/76 (1.32%)  1 0/76 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03478644     History of Changes
Other Study ID Numbers: 203115
First Submitted: March 21, 2018
First Posted: March 27, 2018
Results First Submitted: May 8, 2018
Results First Posted: August 31, 2018
Last Update Posted: October 15, 2018