Integrated Oral Care Intervention for Xerostomia in Diabetes Patients (IOCID)

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetic Neuropathies
• Intervention / Treatment: Procedure: Integrated Oral Care Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Mahdia Babak, BDS, MPH; Phone Number: +92 331 0066683; Email: mahdia.iph@kmu.edu.pk
• Study Contact Backup: Name: Dr. Mohammad Jawad, MBBS, MCPS; Phone Number: +92 334 9011681; Email: mdrjawad@yahoo.com

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Recruiting
      • Lady Reading Hospital
      • Contact: Dr Mahdia Babak, MPH; Phone Number: +92 331 0066683; Email: mahdia.iph@kmu.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Xerostomia Severity Score	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.	Baseline to 2 months after intervention
Change in Oral Health-Related Quality of Life	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.	Baseline to 2 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Oral Health Status	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.	Baseline to 2 months after intervention
Provider Adoption and Implementation Fidelity	Assessment of endocrinologist adherence to the integrated oral-care intervention protocol using structured fidelity checklists and training evaluation tools.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Collaborators: Khyber Teaching Hospital
• Investigators: Principal Investigator: Dr. Mahdia Babak, BDS, MPH, Institute of Public Health, Khyber Medical University (KMU), Peshawar, Pakistan; Study Director: Dr. Zohaib Khan, Director ORIC, KMU; Principal Investigator: Dr. Mohammad Jawad, MBBS, MCPS, Khyber Medical University, Peshawar, Pakistan

Publications and helpful links

General Publications

• Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384.
• Singh A, Shadangi S, Gupta PK, Rana S. Type 2 Diabetes Mellitus: A Comprehensive Review of Pathophysiology, Comorbidities, and Emerging Therapies. Compr Physiol. 2025 Feb;15(1):e70003. doi: 10.1002/cph4.70003.
• Olfson M, King M, Schoenbaum M. Antipsychotic treatment of adults in the United States. J Clin Psychiatry. 2015 Oct;76(10):1346-53. doi: 10.4088/JCP.15m09863.
• Huang S, Zeng X, Deng S, He S, Liu F. Prevalence of xerostomia in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. BMC Oral Health. 2025 Apr 29;25(1):662. doi: 10.1186/s12903-025-05992-6.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Non communicable diseases; Oral health quality of life; Integrated oral care
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Disease Attributes; Metabolic Diseases; Peripheral Nervous System Diseases; Glucose Metabolism Disorders; Diabetes Complications; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Noncommunicable Diseases; Diabetes Mellitus; Diabetic Neuropathies
• Other Study ID Numbers: KMU/DIR/CTU/2025/011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD), including baseline characteristics, outcome measures (Xerostomia Inventory-11, OHIP-14, and OHAT scores), and statistical analysis results, will be shared with qualified researchers upon reasonable request, following publication of the primary study findings. All shared data will be anonymized to ensure participant confidentiality.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
• IPD Sharing Access Criteria: Access to de-identified IPD will be granted to researchers who submit a scientifically sound research proposal, with approval from the principal investigator and institutional ethics committee. A formal data use agreement will be required prior to data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No