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

ISRCTN	ISRCTN39262348
DOI	https://doi.org/10.1186/ISRCTN39262348
Secondary identifying numbers	N/A

Submission date: 03/01/2010
Registration date: 16/03/2010
Last edited: 16/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Prof Antonio Mata
Scientific

Grupo de Investigação em Biologia e Bioquímica Oral
Faculdade de Medicina Dentária da Universidade de Lisboa
Cidade Universitária
Lisbon
1649-003
Portugal

Email	admata2@yahoo.com

Study information

Study design	Two-arm parallel single centre triple-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva of Sjögrens syndrome patients: a two arm parallel single centre randomised controlled trial
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. The rationale for this study being to find out if the use of the Dentaid GSSS increases salivary secretion and is safer regarding dental erosion. The study hypotheses are: 1.There is a significant difference in the salivary pH variation elicited by the new GSSS in patients with Sjögrens syndrome 2.There is a significant difference in the stimulation of whole saliva secretion capacity elicited by the new GSSS with patients with Sjögrens syndrome
Ethics approval(s)	Ethical Committee at the Faculty of Dentistry of the University of Lisbon and the Portuguese Institute for Rheumathological Diseases approved in December 2009
Condition	Primary Sjögren's syndrome
Intervention	Salivary buffering capacity will be assessed in all participants at baseline. The participants will randomly be allocated to the control and intervention arms in equal numbers (40 in each arm): 1. Intervention arm: New Gustatory stimulant of salivary secretion - one lozenge of Dentaid® (Dentaid, Spain) 2. Control arm: Traditional, citric acid based gustatory stimulant of salivary secretion - one lozenge of SST® (Sinclair, UK) Salivary secretion rate and pH changes will be 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)	Dentaid®, SST®
Primary outcome measure	Time of GSSS induced pH drop below 5.5 expressed in minutes as the mean ± 95% confidence interval. In order to better quantify risk differences of GSSS induced pH drop below 5.5 a contingency table compiling the counts of subjects with pH drops below 5.5 for over one minute will be obtained. Additional analyses will be done to calculate association measures like the absolute risk reduction (ARR) and number needed to treat (NNT).
Secondary outcome measures	1. GSSS induced salivary pH variations expressed as the mean ± 95% confidence interval of the three pH measures obtained from salivary samples at defined time points 2. GSSS stimulated salivary flow expressed in ml/min as the mean ± 95% confidence interval of stimulated salivary flow obtained at different time points 3. Overall stimulated salivary flow will also be calculated and expressed in ml/min as the mean ± 95% confidence interval of the total volume of stimulated saliva divided by the total time of each experiment which will be 20 minutes 4. Salivary stimulation output defined as the difference between GSSS and basal salivary flow, expressed as ml/min
Overall study start date	07/01/2010
Overall study end date	07/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Participant inclusion criteria	1. Participants (both males and females) above 18 years 2. Suffering from primary Sjögren's syndrome 3. An unstimulated whole saliva flow less than 0.1 mL/min, and a stimulated whole saliva flow greater than 0.2 mL/min
Participant exclusion criteria	1. Currently taking xerostomic medication 2. Pregnant
Recruitment start date	07/01/2010
Recruitment end date	07/10/2010

Locations

Countries of recruitment

Portugal

Study participating centre

Grupo de Investigação em Biologia e Bioquímica Oral

Lisbon
1649-003
Portugal

Sponsor information

Dentaid, S.L. (Spain)
Industry

Oficinas centrales
Ronda Can Fatjó, 10
Parc Tecnologic Del Valles
Cerdanyola
Barcelona
08290
Spain

Email	dentaid@dentaid.es
Website	http://www.dentaid.com/
"ROR"	https://ror.org/02n9shp96

Funders

Funder type

Industry

Dentaid, S.L. (Spain)

No information available

Results and Publications

Intention to publish date
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

Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva of Sjögrens syndrome patients