Trial Outcomes & Findings for A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers (NCT NCT03345108)
NCT ID: NCT03345108
Last Updated: 2019-03-29
Results Overview
Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.
COMPLETED
NA
48 participants
Upto 9 weeks
2019-03-29
Participant Flow
All the participants were recruited from one center in United States.
A total of 49 participants were screened for entry into the study, of whom 48 were randomized. 1 participant did not meet the study criteria. Out of 48, only 47 subjects started the no adhesive treatment period, since 1 participant discontinued the study due a scheduling (withdrawal of consent).
Participant milestones
| Measure |
A-B-C
Sequence of the treatment if A-B-C, where A-conventional application; B- continuous strip application; C- no adhesive
|
A-C-B
Sequence of the treatment if A-C-B, where A-conventional application; B- continuous strip application; C- no adhesive
|
B-A-C
Sequence of the treatment if B-A-C, where A-conventional application; B- continuous strip application; C- no adhesive
|
B-C-A
Sequence of the treatment if B-C-A, where A-conventional application; B- continuous strip application; C- no adhesive
|
C-A-B
Sequence of the treatment if C-A-B, where A-conventional application; B- continuous strip application; C- no adhesive
|
C-B-A
Sequence of the treatment if C-B-A, where A-conventional application; B- continuous strip application; C- no adhesive
|
|---|---|---|---|---|---|---|
|
Period-1
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Period-1
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Period-1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period-2
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Period-2
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Period-2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period-3
STARTED
|
7
|
8
|
8
|
8
|
8
|
8
|
|
Period-3
COMPLETED
|
7
|
8
|
8
|
8
|
8
|
8
|
|
Period-3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers
Baseline characteristics by cohort
| Measure |
Overall
n=48 Participants
Includes participants with conventional application of adhesive, continuous strip application of adhesive and no adhesive
|
|---|---|
|
Age, Continuous
|
65.0 Years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Current Lower Denture Age
|
11.4 Years
STANDARD_DEVIATION 12.31 • n=93 Participants
|
|
Current Upper Denture Age
|
12.0 Years
STANDARD_DEVIATION 12.25 • n=93 Participants
|
PRIMARY outcome
Timeframe: Upto 9 weeksPopulation: The primary endpoint has been measured for intent-to-treat (ITT) population (N=48). The ITT population included all randomized participants who received at least 1 dose of study treatment during the study and consumed peanuts and had at least 1 mass of peanuts from both upper and lower dentures.
Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.
Outcome measures
| Measure |
Conventional Application
n=48 Participants
Participants received the 1.6 grams (g) of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in conventional pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in short strips (3 strips to the upper denture and 2 strips on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
|
Continuous Strip Application
n=48 Participants
Participants received the 1.6 g of adhesive to the denture which was placed in the mouth as 1.0 g for maxillary denture and 0.6 g for mandibular denture. In this group, the test denture adhesive was applied in continuous strip pattern which is defined as the adhesive was filled in pre-weighed syringe and was applied in long, continuous strips (3 strips to the upper denture and 1 strip on the lower denture), not too close to the denture. Participants rinsed their mouth before inserting the dentures and bit down for few seconds to secure hold.
|
No Adhesive
n=47 Participants
Participants did not receive any denture adhesive in this group.
|
|---|---|---|---|
|
Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)
|
0.01184 Grams
Standard Deviation 0.016237
|
0.00944 Grams
Standard Deviation 0.013326
|
0.07853 Grams
Standard Deviation 0.158567
|
Adverse Events
Conventional Application
Continuous Strip Application
No Adhesive
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place