Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva

ISRCTN	ISRCTN68970559
DOI	https://doi.org/10.1186/ISRCTN68970559
Protocol serial number	N/A
Sponsor	University of Lisbon (Portugal)
Funder	University of Lisbon (Portugal) - Oral and Biomedical Sciences Research Unit (Unidade de Investigação em Ciências Orais e Biomédicas)

Submission date: 27/08/2008
Registration date: 09/10/2008
Last edited: 05/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof António Mata
Scientific

Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal

Email	admata2@yahoo.com

Study information

Primary study design	Interventional
Study design	Two-arm parallel single centre triple-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva: a two arm parallel single centre randomised controlled trial
Study objectives	Gustatory stimulants of salivary secretion (GSSS) are sold over the counter in wide number of European countries and used to stimulate salivary secretion. The acidic nature of these lozenges suggests that they may increase the risk for dental erosion. However, clinical studies on this issue are lacking. More recently a new class of these products has been marketed with the claim that its lower acid content and addition of fluoride and xylitol diminishes the risk for dental erosion. The research questions addressed by this study were to find out if this new class of gustatory stimulants of salivary secretion has comparable efficiency in stimulating salivary secretion and do in fact represent a lower risk for dental erosion. The study hypotheses were: 1. There is a significant difference in the salivary pH variation elicited by the two gustatory stimulants of salivary secretion 2. There is a significant difference in the salivary secretion stimulation capacity elicited by the two gustatory stimulants of salivary secretion
Ethics approval(s)	Ethical Committee at the Higher Institute of Health Sciences Egas Moniz (Instituto Superior de Ciências da Saúde Egas Moniz) approved in October 2006
Health condition(s) or problem(s) studied	Xerostomia
Intervention	Salivary buffering capacity was assessed in all participants at baseline. The participants were randomly allocate to the control and intervention arms in equal numbers (60 in each arm): 1. Intervention arm: Gustatory stimulant of salivary secretion with xylitol and fluoride - one lozenge of Xerodent® (Alpharma, Sweden) 2. Control arm: Traditional, citric acid based gustatory stimulant of salivary secretion - one lozenge of SST® (Sinclair, UK) Salivary secretion rate and pH changes were recorded at defined time intervals (minute 0, 1, 2, 3, 5, 8, 10, 15 and 20) to determine the efficacy of saliva stimulation and dental erosion potential of these lozenges.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Xerodent®, SST®
Primary outcome measure(s)	The following were assessed based on the salivary secretion rate and pH changes recorded at minute 0, 1, 2, 3, 5, 8, 10, 15 and 20 during the interventions (see interventions section): 1. GSSS induced salivary pH variations 2. Time of GSSS induced pH drop below 5.5 3. Absolute risk reduction (ARR) and number needed to treat (NNT), based on the pH variations (see primary outcomes 1 and 2 above) 4. GSSS stimulated salivary flow
Key secondary outcome measure(s)	Salivary secretion capacity defined as the difference between mechanically stimulated and basal salivary flow, expressed as ml/min.
Completion date	02/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Participants (both males and females) aged over 18 years 2. Students of a Portuguese University through 3. Healthy Recruitment was supervised by research assistants.
Key exclusion criteria	1. Presence of systemic pathology 2. Currently taking xerostomic medication
Date of first enrolment	02/09/2007
Date of final enrolment	02/05/2008

Locations

Countries of recruitment

Portugal

Study participating centre

Faculdade de Medicina Dentária

Lisboa
1649-003 LX
Portugal

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No