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. Identifier: NCT01167504
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
Quadram Institute

Study Type: Observational
Condition: Healthy
Intervention: Other: Saliva sample collection

  Participant Flow

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
Saliva Sample Collection Collection of whole mouth and parotid saliva samples

Participant Flow:   Overall Study
    Saliva Sample Collection

  Baseline Characteristics

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
Saliva Sample Collection Collection of whole mouth and parotid saliva

Baseline Measures
   Saliva Sample Collection 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 30.5  (8.7) 
[Units: Participants]
Female   9 
Male   6 
Region of Enrollment 
[Units: Participants]
United Kingdom   15 

  Outcome Measures

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

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

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 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