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

Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva of Sjögren?s syndrome patients: a two arm parallel single centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39262348

Enrollment

Registered

2010-03-16

Start date

2010-01-07

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's syndrome Musculoskeletal Diseases Other systemic involvement of connective tissue

Interventions

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. Int

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Currently taking xerostomic medication 2. Pregnant

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026