Trial Outcomes & Findings for A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive (NCT NCT02937870)
NCT ID: NCT02937870
Last Updated: 2018-05-23
Results Overview
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (pounds \[lbs\]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
COMPLETED
NA
25 participants
up to 12 hours
2018-05-23
Participant Flow
All participants were recruited at a single center in USA.
A total of 37 participants were screened. Out of which 23 participants were randomized in the study. 14 participants were not randomized in the study because 12 of which were screened failure, one participant withdrew consent and one participant was dismissed because number of participants required being reached.
Participant milestones
| Measure |
Overall Study
This was a single-center, randomized, controlled, examiner-blind, four-treatment, four-period, crossover study. Participants received a single application of each study treatment, lasting for 12 hours.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
Received Test Adhesive 1
|
21
|
|
Overall Study
Received Test Adhesive 2
|
22
|
|
Overall Study
Received Positive Control Adhesive
|
21
|
|
Overall Study
Received no Adhesive
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study
This was a single-center, randomized, controlled, examiner-blind, four-treatment, four-period, crossover study. Participants received a single application of each study treatment, lasting for 12 hours.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Deviation
|
2
|
Baseline Characteristics
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=23 Participants
All randomized participants who received all four treatments: test adhesive 1, test adhesive 2, positive control adhesive and no adhesive were included in the baseline assessment.
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 5.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 hoursPopulation: Analysis for this outcome was performed on intent-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (pounds \[lbs\]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Outcome measures
| Measure |
Test Adhesive 1
n=20 Participants
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
No Adhesive
n=20 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
|
2.09 lbs
Standard Error 0.34
|
1.43 lbs
Standard Error 0.33
|
PRIMARY outcome
Timeframe: up to 12 hoursPopulation: Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Outcome measures
| Measure |
Test Adhesive 1
n=21 Participants
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
No Adhesive
n=20 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive
|
1.23 lbs
Standard Error 0.33
|
1.43 lbs
Standard Error 0.33
|
SECONDARY outcome
Timeframe: up to 12 hoursPopulation: Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Outcome measures
| Measure |
Test Adhesive 1
n=20 Participants
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
No Adhesive
n=20 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
|
2.09 lbs
Standard Error 0.34
|
2.02 lbs
Standard Error 0.33
|
SECONDARY outcome
Timeframe: up to 12 hoursPopulation: Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Outcome measures
| Measure |
Test Adhesive 1
n=21 Participants
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
No Adhesive
n=20 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive
|
1.23 lbs
Standard Error 0.33
|
2.02 lbs
Standard Error 0.33
|
SECONDARY outcome
Timeframe: up to 12 hoursPopulation: Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours \[AUC0-12\])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
Outcome measures
| Measure |
Test Adhesive 1
n=20 Participants
Participants of this arm topically applied test adhesive 1 to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
No Adhesive
n=21 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2
|
2.09 lbs
Standard Error 0.34
|
1.23 lbs
Standard Error 0.33
|
Adverse Events
Test Adhesive 1
Test Adhesive 2
Positive Control Adhesive
Negative Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Adhesive 1
n=21 participants at risk
Participants of this arm received topical application of test adhesive 1 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Test Adhesive 2
n=22 participants at risk
Participants of this arm received topical application of test adhesive 2 to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Positive Control Adhesive
n=21 participants at risk
Participants of this arm received topical application of commercial adhesive to upper denture by site study staff, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Negative Control
n=20 participants at risk
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
4.8%
1/21 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/22 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/22 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
4.8%
1/21 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/22 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
4.8%
1/21 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
4.5%
1/22 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
|
General disorders
Injury associated with device
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
4.5%
1/22 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
|
Product Issues
Device breakage
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
4.5%
1/22 • Number of events 1 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/21 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
0.00%
0/20 • up to 61 days (AEs were collected from OST examination from screening to last study visit)
|
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