Trial Outcomes & Findings for A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive (NCT NCT03037307)
NCT ID: NCT03037307
Last Updated: 2018-08-31
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Up to 12 hours
Results posted on
2018-08-31
Participant Flow
All participants were recruited at a single center in the United States.
A total of 53 participants were screened. Out of which 44 participants were randomized in the study. 9 participants were not randomized because they did not meet the study criteria.
Participant milestones
| Measure |
Test Adhesive/No Treatment/Positive Control Adhesive
Participants in this arm received topical application of test adhesive, followed by no treatment, positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products were applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Test Adhesive/Positive Control Adhesive/No Treatment
Participants in this arm received topical application of test adhesive, followed by positive control adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
No Treatment/Test Adhesive/Positive Control Adhesive
Participants in this arm received no treatment, followed by topical application of test adhesive and positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
No Treatment/Positive Control Adhesive/Test Adhesive
Participants in this arm received no treatment, followed by topical application of positive control adhesive and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Positive Control Adhesive/Test Adhesive/No Treatment
Participants in this arm received topical application of positive control adhesive, followed by test adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Positive Control Adhesive/No Treatment/Test Adhesive
Participants in this arm received topical application of positive control adhesive, followed by no treatment and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
8
|
7
|
7
|
8
|
|
Period 1
COMPLETED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Wash Out Period 1
STARTED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Wash Out Period 1
COMPLETED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Wash Out Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Period 2
COMPLETED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash Out Period 2
STARTED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Wash Out Period 2
COMPLETED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Wash Out Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Period 3
COMPLETED
|
7
|
7
|
8
|
6
|
7
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Adhesive/No Treatment/Positive Control Adhesive
Participants in this arm received topical application of test adhesive, followed by no treatment, positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products were applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Test Adhesive/Positive Control Adhesive/No Treatment
Participants in this arm received topical application of test adhesive, followed by positive control adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
No Treatment/Test Adhesive/Positive Control Adhesive
Participants in this arm received no treatment, followed by topical application of test adhesive and positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
No Treatment/Positive Control Adhesive/Test Adhesive
Participants in this arm received no treatment, followed by topical application of positive control adhesive and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Positive Control Adhesive/Test Adhesive/No Treatment
Participants in this arm received topical application of positive control adhesive, followed by test adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Positive Control Adhesive/No Treatment/Test Adhesive
Participants in this arm received topical application of positive control adhesive, followed by no treatment and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
|---|---|---|---|---|---|---|
|
Period 1
Did Not Meet Study Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=44 Participants
All randomized participants who received test adhesive, positive control adhesive and did not receive any treatment were included in the baseline assessment.
|
|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 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
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 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 intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy.
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 |
Positive Control Adhesive
n=44 Participants
Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=44 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)
|
4.78 lbs
Standard Error 0.657
|
2.03 lbs
Standard Error 0.657
|
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.
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 |
Positive Control Adhesive
n=44 Participants
Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=44 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)
|
4.15 lbs
Standard Error 0.659
|
2.03 lbs
Standard Error 0.657
|
Adverse Events
Test Adhesive
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Positive Control Adhesive
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Negative Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overall Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Adhesive
n=42 participants at risk
Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Positive Control Adhesive
n=43 participants at risk
Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=44 participants at risk
Participants of this arm did not receive any adhesive to apply on upper denture.
|
Overall Participants
n=44 participants at risk
This arm included all the participants randomized to receive test adhesive, positive control adhesive and no treatment.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/42 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/43 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/44 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/44 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
|
Injury, poisoning and procedural complications
Mouth injury
|
2.4%
1/42 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/43 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/44 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/44 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/42 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/43 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/44 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/44 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/42 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/43 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/44 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/44 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
|
General disorders
Medical device pain
|
0.00%
0/42 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/43 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
0.00%
0/44 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
2.3%
1/44 • Number of events 1 • up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)
|
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