Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors Controlling the Formation of Salivary Films (SalFilm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167504
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Quadram Institute Bioscience

Study Type Observational
Condition Healthy
Intervention Other: Saliva sample collection
Enrollment 15
Recruitment Details 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.
Pre-assignment Details There were no significant events required following enrollment.
Arm/Group Title Saliva Sample Collection
Hide Arm/Group Description Collection of whole mouth and parotid saliva samples
Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Arm/Group Title Saliva Sample Collection
Hide Arm/Group Description Collection of whole mouth and parotid saliva
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Volunteers were required to donate saliva for ex-vivo study, as described in protocol. A pool of 12 volunteers was maintained. 3 further volunteers had to be recruited following 3 losses due to personal reasons, i.e. not connected with study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
30.5  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 15 participants
15
1.Primary Outcome
Title Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces
Hide Description 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.
Time Frame Within 4 hours of saliva collection.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saliva Sample Collection
Hide Arm/Group Description:
Collection of whole mouth and parotid saliva samples
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nm
27  (8)
2.Secondary Outcome
Title Defined Behaviour of Salivary Film Formation
Hide Description 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.
Time Frame Within 4 hours of saliva collection.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saliva Sample Collection
Hide Arm/Group Description:
Collection of whole mouth and parotid saliva samples
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nm/cm2/min
868  (475)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saliva Sample Collection
Hide Arm/Group Description Collection of whole mouth and parotid saliva samples
All-Cause Mortality
Saliva Sample Collection
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saliva Sample Collection
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saliva Sample Collection
Affected / at Risk (%)
Total   0/15 (0.00%) 
No adverse events were reported. The number of volunteers required gave acceptable statistics as anticipated. The study was completed on time
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Professor Peter Wilde
Organization: Institute of Food Research
Phone: +441603255258
Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT01167504     History of Changes
Other Study ID Numbers: IFR03-2010
First Submitted: July 20, 2010
First Posted: July 22, 2010
Results First Submitted: August 21, 2013
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014