Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva
ISRCTN | ISRCTN68970559 |
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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
Scientific
Faculdade de Medicina Dentária
Universidade de Lisboa
Cidade Universitária
Lisboa
1649-003 LX
Portugal
admata2@yahoo.com |
Study information
Study design | Two-arm parallel single centre triple-blind randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Xerodent®, SST® |
Primary outcome measure | 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 study start date | 02/09/2007 |
Completion date | 02/05/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
1649-003 LX
Portugal
Sponsor information
University of Lisbon (Portugal)
University/education
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
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/04/2009 | Yes | No |