Diabetes (DM)NCT07084532
Effects of Chewing Gum for Dry Mouth in Diabetes
A study testing Chewing gum and Standart therapy group in people with Diabetes (DM) and Dry Mouth, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
Dry mouth can seriously affect the quality of life of individuals because it affects chewing and swallowing functions. One of the diseases in which dry mouth occurs as a side effect of many diseases and/or treatments is diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM), Dry Mouth
- What is being tested?
- Chewing gum and Standart therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 28 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria for individuals in the study were; being diagnosed with type 2 diabetes mellitus, having an HbA1c value of 7% and above, being able to communicate verbally, not having hearing loss, and accepting the voluntary consent form voluntarily.
Who cannot join
- The exclusion criteria for individuals to be included in the study were having additional diseases that caused dry mouth and oral problems and/or using medication or other treatments for this reason (chemotherapy, radiotherapy, Sjögren syndrome, patients who cannot communicate verbally, have hearing problems, do not want to chew gum, use of antihypertensive, anxiolytic and diuretic drugs).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: The Effect of Chewing Gum on Dry Mouth in Individuals With Diabetes Mellitus
Dry mouth can seriously affect the quality of life of individuals because it affects chewing and swallowing functions. One of the diseases in which dry mouth occurs as a side effect of many diseases and/or treatments is diabetes mellitus. The aim of this study was to determine the effect of chewing gum on dry mouth in individuals with diabetes mellitus.
Read the detailed description
Diabetic autonomic neuropathy and microvascular changes in the oral mucosa are thought to cause decreased salivary secretion in individuals. Furthermore, poor blood glucose regulation and the accompanying polyuria can cause dehydration, leading to dry mouth and decreased salivary secretion. Decreased salivary secretion and subsequent changes in the oral mucosa have been reported in diabetic individuals with poor glycemic control.
Chewing gum is one of the activities that increases salivary secretion. It affects salivary pH and flow rate through both taste and mechanical stimulation, relieving dry mouth symptoms in individuals. While the unstimulated salivary flow rate in humans is 0.3 ml/min, this rate can reach 7 ml/min in someone chewing gum. Due to these known properties, chewing gum can be beneficial for dry mouth in individuals.
Literature reviews have shown that chewing gum reduces the feeling of dry mouth, increases salivary secretion, and quenches thirst. It is also believed that increased salivary secretion dilutes the bacterial load in the mouth, thus reducing the risk of periodontal disease. It is anticipated that chewing gum may be a factor that can improve the quality of life for patients with chronic diseases that require fluid restriction and a special diet. A review of the literature found no studies demonstrating the effect of gum chewing on dry mouth in individuals with diabetes.
- Conditions
- Diabetes (DM), Dry Mouth
- Being tested
- Chewing gum, Standart therapy group
- Keywords
- Diabetes Mellitus, Dry Mouth, Chewing Gum, Nursing Care
- Medical subject headings
- Diabetes Mellitus, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
Dry mouth was diagnosed in the initial assessment of diabetic individuals assigned to the intervention group. Following the assessment, they were asked to chew gum for 15 minutes before each main meal for seven days. Dry mouth was re-evaluated with the Xerostomia Scale seven days later.
Standart therapy groupOther
The control group was informed about the study. They were then assessed for dry mouth. They were asked to follow their standard treatment. They were warned not to chew gum. A day later, dry mouth was assessed again without any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group was informed about the study. Dry mouth was noted at baseline. Individuals in the intervention group were asked to chew sugarless gum for 15 minutes before meals and before 3 main meals for 7 days. Receives: Other: Chewing gum |
| Standart Therapy Group | Experimental | Patients in the control group were also informed about the study and completed a data collection form via face-to-face interview. No interventions were performed on the control group patients. They were also informed that they would be re-evaluated one week later during the study and were asked to refrain from chewing gum during this period. Receives: Other: Standart therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in dry mouth in individuals with diabetes
The level of dry mouth of the individuals before and after the intervention was defined by the Xerostomia scale. The scale consists of 11 questions. The lowest possible score is 11 and the highest is 55, with higher scores indicating increased dry mouth.
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start12 Feb 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental in a pre-test-post-test design
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Aybek,, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084532
- Sponsor's protocol ID
- CankırıKU-SBF-SA-01
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No