NCT07084532

Brief 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. The aim of this study was to determine the effect of chewing gum on dry mouth in individuals with diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 13, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

Diabetes MellitusDry MouthChewing GumNursing Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    5

Study Arms (2)

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.

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.

Other: Standart therapy group

Interventions

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.

Intervention Group

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.

Standart Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusXerostomia

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental in a pre-test-post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse

Study Record Dates

First Submitted

June 13, 2025

First Posted

July 24, 2025

Study Start

February 12, 2024

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations