Trial Outcomes & Findings for Factors Controlling the Formation of Salivary Films (NCT NCT01167504)
NCT ID: NCT01167504
Last Updated: 2014-01-06
Results Overview
The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm\^2), density (ng/cm\^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.
COMPLETED
15 participants
Within 4 hours of saliva collection.
2014-01-06
Participant Flow
Recruitment took place between 16/6/2010 and 16/2/2012. A pool of 12 volunteers was required. 12 volunteers were recruited in 2010 and 2011, 3 further volunteers recruited in 2012 to replace 3 volunteers who left the study for personal reasons.
There were no significant events required following enrollment.
Participant milestones
| Measure |
Saliva Sample Collection
Collection of whole mouth and parotid saliva samples
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Factors Controlling the Formation of Salivary Films
Baseline characteristics by cohort
| Measure |
Saliva Sample Collection
n=15 Participants
Collection of whole mouth and parotid saliva
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
30.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 4 hours of saliva collection.Population: Based on published results of saliva pellicle thickness, power calculations showed that 12 individuals would provide sufficient statistical significance to determine the effect of added ingredients on salivary film thickness.
The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm\^2), density (ng/cm\^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.
Outcome measures
| Measure |
Saliva Sample Collection
n=12 Participants
Collection of whole mouth and parotid saliva samples
|
|---|---|
|
Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces
|
27 nm
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Within 4 hours of saliva collection.Population: Literature data and power calculations were used to calculate the number of individuals required to show a statistical significant effect of the presence of ingredients on the thickness of the salivary film.
A secondary output is a well defined description of the film formation behaviour of "normal"saliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance.
Outcome measures
| Measure |
Saliva Sample Collection
n=12 Participants
Collection of whole mouth and parotid saliva samples
|
|---|---|
|
Defined Behaviour of Salivary Film Formation
|
868 nm/cm2/min
Standard Deviation 475
|
Adverse Events
Saliva Sample Collection
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