[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625641":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":33,"studyPopulation":24,"armGroups":34,"interventions":41,"overallOfficials":48,"centralContacts":60,"locations":69,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":24,"maxAge":101,"enrollmentInfo":102,"targetDuration":24,"studyType":105,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline to 2 months after intervention",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":23},"Provider Adoption and Implementation Fidelity","Assessment of endocrinologist adherence to the integrated oral-care intervention protocol using structured fidelity checklists and training evaluation tools.","Baseline to 6 months",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"NA","SINGLE_GROUP","This is a single arm pre post interventional study. All enrolled participants will receive the integrated oral care intervention delivered by trained endocrinologists. Outcomes will be measured at baseline and again after the intervention to assess changes in xerostomia severity and oral health related quality of life.","TREATMENT",{"masking":31,"maskingDescription":32,"whoMasked":24},"NONE","This is an open label study. Due to the nature of the intervention which includes provider delivered counseling screening and referral masking of participants providers investigators and outcome assessors is not feasible.","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.\n\nIn 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.\n\nThe 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.\n\nThe 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.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Integrated Oral Care Intervention","EXPERIMENTAL","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.",[40],"Procedure: Integrated Oral Care Intervention",[42],{"type":43,"name":36,"description":44,"armGroupLabels":45,"otherNames":46},"PROCEDURE","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.",[36],[47],"Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetes",[49,53,57],{"name":50,"affiliation":51,"role":52},"Dr. Mahdia Babak, BDS, MPH","Institute of Public Health, Khyber Medical University (KMU), Peshawar, Pakistan","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":56},"Dr. Zohaib Khan","Director ORIC, KMU","STUDY_DIRECTOR",{"name":58,"affiliation":59,"role":52},"Dr. Mohammad Jawad, MBBS, MCPS","Khyber Medical University, Peshawar, Pakistan",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":24,"email":65},"Dr Mahdia Babak, BDS, MPH","CONTACT","+92 331 0066683","mahdia.iph@kmu.edu.pk",{"name":58,"role":63,"phone":67,"phoneExt":24,"email":68},"+92 334 9011681","mdrjawad@yahoo.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Lady Reading Hospital","RECRUITING","Peshawar","KPK","25000","Pakistan","PK",{"type":79,"coordinates":80},"Point",[81,82],71.57849,34.008,{"lat":82,"lon":81},[85],{"name":86,"role":63,"phone":64,"phoneExt":24,"email":65},"Dr Mahdia Babak, MPH",{"type":88,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[90],{"name":91,"class":6},"Khyber Teaching Hospital","100625641","integrated-oral-care-intervention-for-xerostomia-in-diabetes-patients-100625641",false,"NCT07425275","Integrated Oral Care Intervention for Xerostomia in Diabetes Patients","The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients","IOCID","Inclusion Criteria:\n\n* Presence of a single stone in the renal pelvis.\n* Age less than 18 years.\n* No congenital or acquired urinary tract abnormalities.\n* No pre-existing chest diseases (e.g., chronic lung disease, pleural effusion).\n\nExclusion Criteria:\n\n* Patients with multiple kidney stones.\n* Calyceal stones (stones located specifically in a calyx).\n* Pelviureteric junction obstruction (PUJO).\n* Pelvic kidney (renal ectopia).","ALL","18 Years",{"count":103,"type":104},80,"ESTIMATED","INTERVENTIONAL",[26],"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.",[109,110],"Diabetes Mellitus","Diabetic Neuropathies",[112,113,114,115],"Diabetes mellitus","Oral health quality of life","Non communicable diseases","Integrated oral care","2026-08-16",{"date":118,"type":119},"2026-08-18","ACTUAL",{"date":121,"type":119},"2026-08-01",{"date":123,"type":104},"2027-01-30",{"name":5,"class":6},1]