Trial Outcomes & Findings for Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe (NCT NCT03478644)
NCT ID: NCT03478644
Last Updated: 2018-10-15
Results Overview
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).
COMPLETED
NA
152 participants
up to 14 days
2018-10-15
Participant Flow
All participants were recruited at one center in the United States.
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.
Participant milestones
| Measure |
Experimental Denture Wipe
All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Phase 1
STARTED
|
31
|
0
|
|
Phase 1
COMPLETED
|
31
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
|
Phase 2
STARTED
|
76
|
76
|
|
Phase 2
COMPLETED
|
73
|
75
|
|
Phase 2
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Experimental Denture Wipe
All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Phase 2
Withdrawal by Subject
|
2
|
1
|
|
Phase 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe
Baseline characteristics by cohort
| Measure |
Experimental Denture Wipe
n=76 Participants
All the participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 Participants
All the participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
60.99 years
STANDARD_DEVIATION 12.702 • n=5 Participants
|
61.03 years
STANDARD_DEVIATION 12.622 • n=7 Participants
|
61.01 years
STANDARD_DEVIATION 12.620 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 14 daysPopulation: 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.
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).
Outcome measures
| Measure |
Experimental Denture Wipe
n=76 Participants
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 Participants
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use
|
0.039 Proportion of participants
Interval 0.01 to 0.11
|
0.013 Proportion of participants
Interval 0.0 to 0.07
|
PRIMARY outcome
Timeframe: up to 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Experimental Denture Wipe
n=76 Participants
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 Participants
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use
|
0.013 Proportion of participants
Interval 0.0 to 0.07
|
0.000 Proportion of participants
Interval 0.0 to 0.05
|
SECONDARY outcome
Timeframe: Day 7, Day 14Population: 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.
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.
Outcome measures
| Measure |
Experimental Denture Wipe
n=76 Participants
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 Participants
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use
At Day 7
|
0 Proportion of participants
|
0 Proportion of participants
|
|
Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use
At Day 14
|
0 Proportion of participants
|
0 Proportion of participants
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
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.
Outcome measures
| Measure |
Experimental Denture Wipe
n=76 Participants
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 Participants
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q1: Score 0 - Not fresh at all
|
20 Participants
|
18 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q1: Score 1 - Slightly fresh
|
16 Participants
|
26 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q1: Score 2 - Moderately fresh
|
18 Participants
|
17 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q1: Score 3 - Very fresh
|
14 Participants
|
10 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q1: Score 4 - Extremely fresh
|
8 Participants
|
5 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q2: Score 0 - Not clean at all
|
12 Participants
|
12 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q2: Score 1 - Slightly clean
|
12 Participants
|
23 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q2: Score 2 - Moderately clean
|
26 Participants
|
21 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q2: Score 3 - Very clean
|
15 Participants
|
14 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q2: Score 4 - Extremely clean
|
11 Participants
|
6 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q3: Score 0 - Not clean at all
|
5 Participants
|
1 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q3: Score 1 - Slightly clean
|
15 Participants
|
15 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q3: Score 2 - Moderately clean
|
23 Participants
|
31 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q3: Score 3 - Very clean
|
23 Participants
|
21 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q3: Score 4 - Extremely clean
|
10 Participants
|
8 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q4: Score 0 - Not fresh at all
|
0 Participants
|
0 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q4: Score 1 - Slightly fresh
|
0 Participants
|
3 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q4: Score 2 - Moderately fresh
|
11 Participants
|
22 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q4: Score 3 - Very fresh
|
32 Participants
|
31 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q4: Score 4 - Extremely fresh
|
33 Participants
|
20 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q5: Score 0 - Not clean at all
|
0 Participants
|
1 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q5: Score 1 - Slightly clean
|
1 Participants
|
0 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q5: Score 2 - Moderately clean
|
9 Participants
|
18 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q5: Score 3 - Very clean
|
32 Participants
|
37 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q5: Score 4 - Extremely clean
|
34 Participants
|
20 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q6: Score 0 - Not clean at all
|
0 Participants
|
0 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q6: Score 1 - Slightly clean
|
1 Participants
|
1 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q6: Score 2 - Moderately clean
|
10 Participants
|
18 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q6: Score 3 - Very clean
|
33 Participants
|
37 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q6: Score 4 - Extremely clean
|
32 Participants
|
20 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q7: Score 0 - Not satisfied at all
|
0 Participants
|
0 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q7: Score 1 - Slightly satisfied
|
0 Participants
|
0 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q7: Score 2 - Moderately satisfied
|
9 Participants
|
21 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q7: Score 3 - Very satisfied
|
40 Participants
|
36 Participants
|
|
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Q7: Score 4 - Extremely satisfied
|
27 Participants
|
19 Participants
|
Adverse Events
Experimental Denture Wipe
Water Rinse
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Denture Wipe
n=76 participants at risk
Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily.
|
Water Rinse
n=76 participants at risk
Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Mouth Injury
|
2.6%
2/76 • Number of events 2 • Approximately 17 days (from Screening Visit to Visit 3)
|
0.00%
0/76 • Approximately 17 days (from Screening Visit to Visit 3)
|
|
Injury, poisoning and procedural complications
Lip Injury
|
1.3%
1/76 • Number of events 1 • Approximately 17 days (from Screening Visit to Visit 3)
|
0.00%
0/76 • Approximately 17 days (from Screening Visit to Visit 3)
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/76 • Approximately 17 days (from Screening Visit to Visit 3)
|
1.3%
1/76 • Number of events 1 • Approximately 17 days (from Screening Visit to Visit 3)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER