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
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Feb 2026
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
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 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
February 20, 2026
February 1, 2026
5 months
February 16, 2026
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Change in Clinical Oral Health Status
Baseline to 2 months after intervention
Provider Adoption and Implementation Fidelity
Baseline to 6 months
Study Arms (1)
Integrated Oral Care Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Patients with multiple kidney stones.
- Calyceal stones (stones located specifically in a calyx).
- Pelviureteric junction obstruction (PUJO).
- Pelvic kidney (renal ectopia).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khyber Medical University Peshawarlead
- Khyber Teaching Hospitalcollaborator
Study Sites (1)
Lady Reading Hospital
Peshawar, KPK, 25000, Pakistan
Related Publications (4)
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.
PMID: 39980164BACKGROUNDOlfson 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.
PMID: 26528641BACKGROUNDFox 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.
PMID: 3858368BACKGROUNDHuang 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.
PMID: 40301819BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- This is an open label study. Due to the nature of the intervention which includes provider delivered counseling screening and referral masking of participants providers investigators and outcome assessors is not feasible.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2026
First Posted
February 20, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
June 25, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
- 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.
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.