Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID07425275

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

Led by Khyber Medical University Peshawar · Updated on 2026-02-20

80

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

Sponsors

K

Khyber Medical University Peshawar

Lead Sponsor

K

Khyber Teaching Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to assess whether simple oral care actions performed by endocrinologists during routine diabetes clinic visits can improve symptoms of dry mouth, also called xerostomia, and enhance oral health-related quality of life for adult diabetes patients. The study focuses on patients experiencing dry mouth, a common condition in diabetes that affects eating, speaking, and overall oral health. It also explores how oral care can be integrated into regular diabetes management in settings with limited dental care access. The intervention involves training endocrinologists to screen for dry mouth using a brief question and the Xerostomia Inventory, examine the mouth for dryness signs, provide brief counseling on hydration and oral hygiene, prescribe saliva substitutes like sprays or gels, and refer patients to dental services if needed. This integrated oral care is delivered during regular diabetes clinic visits, and all participants receive the intervention. Assessments occur before and after the intervention to evaluate changes. Participants will be followed from baseline through follow-up visits to measure changes in dry mouth severity and oral health quality of life using validated tools including the Xerostomia Inventory and Oral Health Impact Profile 14. Oral health status will be clinically assessed with the Oral Health Assessment Tool. The study will also evaluate how well the intervention is adopted and delivered by providers, and explore barriers and facilitators through interviews. The total participation duration includes assessments up to two months after the intervention with implementation outcomes monitored up to six months.

CONDITIONS

Brief Title

Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 such as chronic lung disease or pleural effusion.
Not Eligible

You will not qualify if you...

  • Patients with multiple kidney stones.
  • Calyceal stones (stones located specifically in a calyx).
  • Pelviureteric junction obstruction (PUJO).
  • Pelvic kidney (renal ectopia).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 months

Participants receive an integrated oral care intervention delivered by trained endocrinologists during routine diabetes clinic visits. This includes screening for dry mouth symptoms, oral examination, counseling on oral hydration and hygiene, prescription of saliva substitutes when needed, and referral to dental care services.

Visits occur during routine diabetes clinic appointments over the intervention period

Follow-up

Duration - Up to 2 months after treatment

Participants are assessed for changes in dry mouth severity, oral health-related quality of life, and clinical oral health status up to 2 months after the intervention to evaluate its effectiveness.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Lady Reading Hospital

Peshawar, KPK, Pakistan, 25000

Actively Recruiting

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Research Team

D

Dr Mahdia Babak, BDS, MPH

D

Dr. Mohammad Jawad, MBBS, MCPS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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