NCT07425275

Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Khyber Medical University Peshawar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This mixed methods pre post implementation study aims to assess the effectiveness and feasibility of integrating basic oral health care into routine diabetes management. Diabetes related xerostomia is a common but under addressed condition that increases the risk of dental caries periodontal disease oral infections and reduced quality of life. In low and middle income settings access to dental care is limited and endocrinologists often serve as the primary point of contact for diabetes patients. In this study endocrinologists at Khyber Medical University affiliated hospitals will receive structured training on oral health screening counseling prescription of saliva substitutes and referral pathways to dental services. Adult patients with type 1 or type 2 diabetes who report symptoms of dry mouth will be enrolled through consecutive sampling during outpatient clinic visits. The intervention includes four core components screening counseling prescribing topical saliva substitutes and referral to dental care. Outcomes will be assessed at baseline and follow up using validated tools including the Xerostomia Inventory and the Oral Health Impact Profile 14. Oral health status will also be assessed using the Oral Health Assessment Tool. Implementation outcomes such as reach adoption fidelity and acceptability will be evaluated using the RE AIM framework while contextual barriers and facilitators will be explored through interviews guided by the Consolidated Framework for Implementation Research. The findings will provide evidence on the clinical effectiveness and implementation feasibility of endocrinologist delivered oral care interventions and will inform policy recommendations for integrating oral health into non communicable disease services in Pakistan.

Conditions

• Diabetes Mellitus
• Diabetic Neuropathies

Interventions

Type	Name	Description
PROCEDURE	Integrated Oral Care Intervention	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-25
• Completion: 2026-07-30
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Pakistan