An interventional study of Integrated Oral Care Intervention in Diabetes Mellitus and Diabetic Neuropathies, sponsored by Khyber Medical University Peshawar. Recruiting at 1 site in Pakistan. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
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.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's planned enrollment of 80 is above the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Khyber Medical University Peshawar is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
Compared within Diabetic Neuropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Also known as: Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetes
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.
Time frame: 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.
Time frame: Baseline to 2 months after intervention
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.
Time frame: 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.
Time frame: Baseline to 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 4 months is below that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.
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Khyber Medical University Peshawar