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NCT Number: NCT07425275

Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of a single stone in the renal pelvis.
  • Age less than 18 years.
  • No congenital or acquired urinary tract abnormalities.
  • No pre-existing chest diseases (e.g., chronic lung disease, pleural effusion).

Exclusion criteria

  • Patients with multiple kidney stones.
  • Calyceal stones (stones located specifically in a calyx).
  • Pelviureteric junction obstruction (PUJO).
  • Pelvic kidney (renal ectopia).

Treatment and study plan

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.

Other names: Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetes

Primary outcomes

  1. Change in Xerostomia Severity Score

    Time frame: Baseline to 2 months after intervention

    Change in xerostomia severity measured using the Xerostomia Inventory-11 (XI-11) questionnaire, comparing baseline and post-intervention scores. The XI-11 score ranges from 11 to 55, with higher scores indicating greater severity of dry mouth.

  2. Change in Oral Health-Related Quality of Life

    Time frame: Baseline to 2 months after intervention

    Change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), comparing baseline and post-intervention scores. Total score ranges from 0 to 56, with higher scores indicating poorer quality of life.

Secondary outcomes

  1. Change in Clinical Oral Health Status

    Time frame: Baseline to 2 months after intervention

    Change in oral health status assessed using the Oral Health Assessment Tool (OHAT), evaluating eight oral health domains. Higher total scores indicate poorer oral health.

  2. Provider Adoption and Implementation Fidelity

    Time frame: Baseline to 6 months

    Assessment of endocrinologist adherence to the integrated oral-care intervention protocol using structured fidelity checklists and training evaluation tools.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Mahdia Babak, BDS, MPH

CONTACT

[email protected]

+92 331 0066683

Dr. Mohammad Jawad, MBBS, MCPS

CONTACT

[email protected]

+92 334 9011681

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Khyber Teaching Hospital

Registry information

Official study title

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

Acronym: IOCID

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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