Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

Sponsor
Khyber Medical University Peshawar
Study ID
NCT07425275
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Diabetic Neuropathies

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Integrated Oral Care Intervention — PROCEDURE
    The integrated oral care intervention consists of a structured set of oral health actions delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question followed by the Xerostomia Inventory for participants who screen positive. A focused oral examination is performed to identify signs of oral dryness and related oral health problems. Participants receive brief counseling on oral hydration strategies oral hygiene practices use of fluoride products and lifestyle measures to relieve dry mouth symptoms. Topical saliva substitute products such as sprays or gels are prescribed when indicated. Participants are also referred to dental services for further evaluation and management when clinically required. The intervention is delivered to all participants and outcomes are assessed before and after the intervention.

Study Details

Diabetes patients commonly experience dry mouth also known as xerostomia which can affect eating speaking oral health and overall quality of life. This study evaluates whether simple oral care actions delivered by endocrinologists during routine diabetes clinic visits can improve dry mouth symptoms and oral health related quality of life. Endocrinologists will be trained to screen for dry mouth provide brief counseling prescribe saliva substitutes and refer patients to dental services when needed. Adult patients with diabetes and symptoms of dry mouth will be followed before and after the intervention to assess changes in xerostomia severity and oral health outcomes. The study will also explore barriers and facilitators to integrating oral health care into routine diabetes management in Pakistan.

Key Dates

First listed
Feb 20, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Dec 25, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Integrated Oral Care Intervention
    Participants in this arm will receive an integrated oral care intervention delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question and the Xerostomia Inventory, oral examination for signs of dry mouth, brief counseling on oral hydration and oral hygiene practices, prescription of topical saliva substitute products as needed, and referral to dental services for further evaluation and management. Outcomes will be assessed at baseline and at follow up to evaluate changes in xerostomia severity and oral health related quality of life.

Primary Outcome Measure

Change in Xerostomia Severity Score [ Time Frame: Baseline to 2 months after intervention ]

Central Contacts

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