Trial Outcomes & Findings for Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress (NCT NCT02928380)

Last Updated: 2018-08-27

Results Overview

Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

Up to 17 days

Results posted on

2018-08-27

Participant Flow

Participants were recruited at a single center in the United States.

A total of 91 participants were screened, out of which only 83 participants were randomized to the study. 8 participants were not randomized: 7 participants due to screening failure and 1 participant due lost to follow up.

Participant milestones

Participant milestones
Measure	Reference Denture Adhesive/Test Denture Adhesive/No Adhesive Participants received reference denture adhesive, test denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.	Reference Denture Adhesive/No Adhesive/Test Denture Adhesive Participants received reference denture adhesive, no adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.	Test Denture Adhesive/Reference Denture Adhesive/No Adhesive Participants received test denture adhesive, reference denture adhesive and no adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.	Test Denture Adhesive/No Adhesive/Reference Denture Adhesive Participants received test denture adhesive, no adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.	No Adhesive/Reference Denture Adhesive/Test Denture Adhesive Participants received no adhesive, reference denture adhesive and test denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.	No Adhesive/Test Denture Adhesive/Reference Denture Adhesive Participants received no adhesive, test denture adhesive and reference denture adhesive by site staff in treatment periods 1, 2, 3 respectively, to their dentures which were placed in their mouth. A single application of each adhesive was applied. The three treatment periods were separated by a washout period of 2-7 days.
Period 1 STARTED	13	14	14	14	14	14
Period 1 COMPLETED	13	14	14	14	14	14
Period 1 NOT COMPLETED	0	0	0	0	0	0
Wash Out Period 1 STARTED	13	14	14	14	14	14
Wash Out Period 1 COMPLETED	13	14	14	14	14	14
Wash Out Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	13	14	14	14	14	14
Period 2 COMPLETED	13	14	14	14	14	14
Period 2 NOT COMPLETED	0	0	0	0	0	0
Wash Out Period 2 STARTED	13	14	14	14	14	14
Wash Out Period 2 COMPLETED	13	14	14	14	14	14
Wash Out Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	13	14	14	14	14	14
Period 3 COMPLETED	13	14	14	14	14	14
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=83 Participants All the participants received all three treatments (reference denture adhesive, test denture adhesive and no adhesive) in the study period 1, 2, and 3 according to the randomization sequence. Each treatment period was separated by washout period of 2-7 days. All randomized participants were included for baseline evaluation.
Age, Continuous	63.4 Years STANDARD_DEVIATION 12.99 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	70 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 17 days

Population: Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) Participants did not receive any denture adhesive by site staff in this treatment arm.
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use	0.06 gram (g) Standard Deviation 0.057	0.08 gram (g) Standard Deviation 0.151	—

SECONDARY outcome

Timeframe: Up to 17 days

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) Participants did not receive any denture adhesive by site staff in this treatment arm.
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use	0.07 g Standard Deviation 0.092	0.08 g Standard Deviation 0.151	—

SECONDARY outcome

Timeframe: up to 17 days

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) Participants did not receive any denture adhesive by site staff in this treatment arm.
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive	0.07 g Standard Deviation 0.092	0.06 g Standard Deviation 0.057	—

SECONDARY outcome

Timeframe: Up to 17 days

Kapur (Olshan modification) Index score was assessed to examine each denture (upper \& lower) for retention \& stability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull \& lateral force: 5=Excellent;4=Very Good;3=Good;2=Fair;1= Poor;0=No retention. Stability was measured as score of 0-4 to assess nature of rocking offered by denture base on its supporting structures under pressure:4=Excellent (no rocking);3=Good (very slight rocking);2=Fair (slight rocking);1=Poor (moderate rocking);0=No stability (extreme rocking). Composite Kapur (Olshan modification) Index scores was measured as the sum score of retention \& stability for upper or lower dentures separately such that a sum score of zero represents no retention and stability and a sum score of 9 represents excellent retention and stability.

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability For Upper Denture	8.67 scores on a scale Standard Deviation 0.828	8.84 scores on a scale Standard Deviation 0.594	8.35 scores on a scale Standard Deviation 1.224
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability For Lower Denture	7.42 scores on a scale Standard Deviation 1.815	8.11 scores on a scale Standard Deviation 1.593	6.36 scores on a scale Standard Deviation 1.535

SECONDARY outcome

Timeframe: Up to 17 days

Kapur (Olshan modification) Index scores were assessed to examine each denture (upper \& lower) for its retention ability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull \& lateral force: 5=Excellent - denture offered excellent resistance to vertical pull and lateral force; 4= Very Good- denture offered very good resistance to vertical pull and lateral force; 3= Good- denture offered moderate resistance to vertical pull and lateral force; 2= Fair- denture offered moderate resistance to vertical pull and little or no resistance to lateral forces; 1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral force; 0= No retention- when the denture was seated in place, it displaced itself. Higher the score, higher the retention ability of denture.

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.
Kapur (Olshan Modification) Index Scores for Denture Retention For Upper Denture	4.80 scores on a scale Standard Deviation 0.512	4.90 scores on a scale Standard Deviation 0.335	4.63 scores on a scale Standard Deviation 0.728
Kapur (Olshan Modification) Index Scores for Denture Retention For Lower Denture	4.05 scores on a scale Standard Deviation 1.070	4.43 scores on a scale Standard Deviation 0.940	3.46 scores on a scale Standard Deviation 0.874

SECONDARY outcome

Timeframe: Up to 17 days

Kapur (Olshan modification) Index scores were assessed to examine each denture (upper \& lower) for its stability ability. Stability was measured using score of 0-4: 4= Excellent- when denture base offered no rocking on its supporting structures under pressure; 3= Good- when denture base had very slight rocking on its supporting structures under pressure; 2= Fair- when denture base had slight rocking on its supporting structures under pressure; 1= Poor- when denture base had moderate rocking on its supporting structures under pressure; 0= No stability- when denture base had extreme rocking under pressure. Higher the score, higher the stability ability of denture.

Outcome measures

Outcome measures
Measure	Reference Denture Adhesive n=83 Participants Participants received reference denture adhesive by site staff as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.	No Adhesive (Negative Control) n=83 Participants Participants did not receive any denture adhesive by site staff in this treatment arm.
Kapur (Olshan Modification) Index Scores for Denture Stability For Upper Denture	3.88 scores on a scale Standard Deviation 0.363	3.94 scores on a scale Standard Deviation 0.286	3.72 scores on a scale Standard Deviation 0.570
Kapur (Olshan Modification) Index Scores for Denture Stability For Lower Denture	3.37 scores on a scale Standard Deviation 0.807	3.67 scores on a scale Standard Deviation 0.700	2.90 scores on a scale Standard Deviation 0.775

Adverse Events

Reference Denture Adhesive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Denture Adhesive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Adhesive (Negative Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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