Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva of patients with head and neck cancer after radiotherapy

Effects of gustatory stimulants of salivary secretion on the pH and stimulation of saliva of patients with head and neck cancer after radiotherapy: a two-arm cross-over single-centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15985810

Enrollment

Registered

2012-03-29

Start date

2011-07-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Dental erosion in patients with head and neck cancer after radiotherapy Oral Health Erosion of teeth

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): Inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants (both males and females) above 18 years 2. Patients after head and neck radiotherapy 3. An unstimulated whole saliva flow less than 0.1 mL/min 4. A stimulated whole saliva flow greater than 0.2 mL/min

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Time of GSSS induced pH drop below 5.5 expressed in minutes as the mean ± 95% confidence interval 2. 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 3. Additional analyses will be done to calculate association measures like the absolute risk reduction (ARR) and number needed to treat (NNT)	—

Measure

Time frame

1. Time of GSSS induced pH drop below 5.5 expressed in minutes as the mean ± 95% confidence interval 2. 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 3. Additional analyses will be done to calculate association measures like the absolute risk reduction (ARR) and number needed to treat (NNT)

—

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

—

Countries

Portugal

Outcome results

None listed

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