Integrated Oral Care Intervention for Xerostomia in Diabetes Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Change in Xerostomia Severity Score [Срок оценки: Baseline to 2 months after intervention]
• Change in Oral Health-Related Quality of Life [Срок оценки: Baseline to 2 months after intervention]

Вторичные конечные точки (2)

• Change in Clinical Oral Health Status [Срок оценки: Baseline to 2 months after intervention]
• Provider Adoption and Implementation Fidelity [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Lady Reading Hospital — Peshawar

Публикации

• 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 39980164
• Olfson 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 26528641
• Fox 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 3858368
• Huang 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 40301819

Идентификаторы

NCT: NCT07425275 · KMU/DIR/CTU/2025/011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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