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A Multicentre Randomized Controlled Trial of two interventions to manage dry mouth in pre-operative elective surgical patients.

A Multicentre Randomized Controlled Trial of two interventions to manage dry mouth in pre-operative elective surgical patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000132145
Acronym
I AM DRY
Enrollment
70
Registered
2019-01-30
Start date
2019-03-14
Completion date
2020-07-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Dry mouth, associated with fasting, stress, anxiety and pharmacological agents has been identified to be the most common perioperative patient complaint. In the pre-operative setting, dry mouth and thirst can be difficult to separate. Patient reported outcome measures such as pain, anxiety and nausea have multiple therapeutic options. Dry mouth is an important, but often overlooked patient reported outcome measure, with few therapeutic options. Dry mouth, is amenable to therapies including saliva substitutes, saliva stimulants and intravenous sialogues in oncological patients following surgery or radiotherapy and in autoimmune conditions. To date, the efficacy of these treatments has not been tested in the perioperative setting. Following a recent pilot study, BIG DRY aims to reduce the feeling of dry mouth in perioperative patients by comparing two simple treats, mouth wash and water.

Interventions

Saliva Substitute - Biotene Dry Mouth Oral Rinse Preoperative patients who have offered their informed consent will be given 15 mls of Biotene to rinse their mouth. The patient is allowed to rinse their mouth for as long as they like and then spit out the liquid. Patients will be asked to complete a Dry Mouth Score pre-intervention and 30 minutes post-treatment. The treatment can be repeated hourly until participants are transferred to the operating rooms from the preoperative area (there is

Saliva Substitute - Biotene Dry Mouth Oral Rinse Preoperative patients who have offered their informed consent will be given 15 mls of Biotene to rinse their mouth. The patient is allowed to rinse their mouth for as long as they like and then spit out the liquid. Patients will be asked to complete a Dry Mouth Score pre-intervention and 30 minutes post-treatment. The treatment can be repeated hourly until participants are transferred to the operating rooms from the preoperative area (there is no maximum time as patient stays in the preoperative are varied).

Sponsors

Dr Doug Campbell
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective surgery who meet all of the following criteria: Elective adult surgical patients aged 18 years of age and older who: Are able to consent to participate AND, Have complied with local hospital fasting guidelines.

Exclusion criteria

Patients who did not comply with fasting guidelines. Patients undergoing acute surgery. Patients who do not give or cannot give consent to participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026