Integrated Oral Care Intervention for Xerostomia in Diabetes Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorKhyber Medical University Peshawar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients with multiple kidney stones.
Calyceal stones (stones located specifically in a calyx).
Pelviureteric junction obstruction (PUJO).
Pelvic kidney (renal ectopia).
Trial design
Design model
Single group
Treatments tested in this trial
Integrated Oral Care Intervention
Procedure/SurgeryThe 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Integrated Oral Care InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 intervention2
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 interventionSecondary outcomes
1
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 intervention2
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 monthsSponsors and contacts
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Khyber Medical University Peshawar
Lead sponsor
Khyber Teaching Hospital
Collaborator
Source ClinicalTrials.gov