Contact information
Type
Scientific
Primary contact
Prof António Mata
ORCID ID
Contact details
Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal
admata2@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Ethical Committee at the Higher Institute of Health Sciences Egas Moniz (Instituto Superior de Ciências da Saúde Egas Moniz) approved in October 2006
Study design
Two-arm parallel single centre triple-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
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 names
Xerodent®, SST®
Primary outcome measures
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
Secondary outcome measures
Salivary secretion capacity defined as the difference between mechanically stimulated and basal salivary flow, expressed as ml/min.
Overall trial start date
02/09/2007
Overall trial end date
02/05/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Presence of systemic pathology
2. Currently taking xerostomic medication
Recruitment start date
02/09/2007
Recruitment end date
02/05/2008
Locations
Countries of recruitment
Portugal
Trial participating centre
Faculdade de Medicina Dentária
Lisboa
1649-003 LX
Portugal
Funders
Funder type
University/education
Funder name
University of Lisbon (Portugal) - Oral and Biomedical Sciences Research Unit (Unidade de Investigação em Ciências Orais e Biomédicas)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19220764
Publication citations
-
Results
da Mata AD, da Silva Marques DN, Silveira JM, Marques JR, de Melo Campos Felino ET, Guilherme NF, Effects of gustatory stimulants of salivary secretion on salivary pH and flow: a randomized controlled trial., Oral Dis, 2009, 15, 3, 220-228, doi: 10.1111/j.1601-0825.2009.01513.x.