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

ISRCTN ISRCTN68970559
DOI https://doi.org/10.1186/ISRCTN68970559
Secondary identifying numbers N/A
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

Study designTwo-arm parallel single centre triple-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleEffects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva: a two arm parallel single centre randomised controlled trial
Study objectivesGustatory 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) studiedXerostomia
InterventionSalivary 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Xerodent®, SST®
Primary outcome measureThe 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 measuresSalivary secretion capacity defined as the difference between mechanically stimulated and basal salivary flow, expressed as ml/min.
Overall study start date02/09/2007
Completion date02/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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 criteria1. Presence of systemic pathology
2. Currently taking xerostomic medication
Date of first enrolment02/09/2007
Date of final enrolment02/05/2008

Locations

Countries of recruitment

  • Portugal

Study participating centre

Faculdade de Medicina Dentária
Lisboa
1649-003 LX
Portugal

Sponsor information

University of Lisbon (Portugal)
University/education

Unidade de Investigação em Ciências Orais e Biomédicas (UICOB)
Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal

ROR logo "ROR" https://ror.org/01c27hj86

Funders

Funder type

University/education

University of Lisbon (Portugal) - Oral and Biomedical Sciences Research Unit (Unidade de Investigação em Ciências Orais e Biomédicas)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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