Factors Controlling the Formation of Salivary Films (SalFilm)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01167504
First received: July 20, 2010
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: August 21, 2013  
Study Type: Observational
Condition: Healthy
Intervention: Other: Saliva sample collection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events required following enrollment.

Reporting Groups
  Description
Saliva Sample Collection Collection of whole mouth and parotid saliva samples

Participant Flow:   Overall Study
    Saliva Sample Collection  
STARTED     15  
COMPLETED     12  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Saliva Sample Collection Collection of whole mouth and parotid saliva

Baseline Measures
    Saliva Sample Collection  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.5  ± 8.7  
Gender  
[units: participants]
 
Female     9  
Male     6  
Region of Enrollment  
[units: participants]
 
United Kingdom     15  



  Outcome Measures
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1.  Primary:   Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces   [ Time Frame: Within 4 hours of saliva collection. ]

2.  Secondary:   Defined Behaviour of Salivary Film Formation   [ Time Frame: Within 4 hours of saliva collection. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No adverse events were reported. The number of volunteers required gave acceptable statistics as anticipated. The study was completed on time


  More Information
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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
e-mail: peter.wilde@ifr.ac.uk


No publications provided


Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT01167504     History of Changes
Other Study ID Numbers: IFR03-2010
Study First Received: July 20, 2010
Results First Received: August 21, 2013
Last Updated: November 14, 2013
Health Authority: United Kingdom: Research Ethics Committee