Integrated oral care for dry mouth in adults with diabetes
The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients
This study will test whether simple oral care steps given by diabetes doctors during routine clinic visits can reduce dry mouth and improve oral health for adults with diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 1 site (Peshawar, KPK) |
| Trial ID | NCT07425275 on ClinicalTrials.gov |
What this trial studies
Endocrinologists at Khyber Medical University–affiliated hospitals will be trained to screen for dry mouth, provide brief counseling, prescribe topical saliva substitutes, and refer patients to dental services. Adults with type 1 or type 2 diabetes who report symptoms of xerostomia will be enrolled consecutively during outpatient visits and followed before and after the intervention. Outcomes include xerostomia severity (Xerostomia Inventory), oral health–related quality of life (OHIP-14), and objective oral health status (Oral Health Assessment Tool). Implementation metrics (reach, adoption, fidelity, acceptability) will be measured using the RE-AIM framework and contextual factors explored through interviews guided by CFIR.
Who should consider this trial
Good fit: Adults with type 1 or type 2 diabetes who report symptoms of dry mouth and attend participating endocrinology clinics in Peshawar are ideal candidates.
Not a fit: Patients without symptoms of dry mouth, those who require advanced dental or surgical treatment for oral disease, or those unable to attend the enrolled clinics are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients could have less dry mouth, fewer oral health problems, and improved eating, speaking, and quality of life from simple care delivered during diabetes visits.
How similar studies have performed: Use of saliva substitutes and brief oral-care counseling has shown symptomatic benefit in other populations, but integrating routine oral screening and referral into diabetes clinics is relatively novel with limited prior implementation data.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Peshawar, KPK
- Lady Reading Hospital — Peshawar, Kpk, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr. Mahdia Babak, BDS, MPH — Institute of Public Health, Khyber Medical University (KMU), Peshawar, Pakistan
- Study coordinator: Dr Mahdia Babak, BDS, MPH
- Email: mahdia.iph@kmu.edu.pk
- Phone: +92 331 0066683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.