[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612671":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":33,"responsibleParty":48,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Dow University of Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Surgical Periodontal Therapy (Scaling and Root Planing + Oral Hygiene Instructions)","EXPERIMENTAL","Participants in this arm will receive full-mouth non-surgical periodontal therapy, including ultrasonic scaling and manual root planing in a single session performed by trained dental hygienists. This treatment aims to remove supra- and subgingival plaque and calculus to reduce periodontal inflammation. Standardized oral hygiene instructions will also be provided, including demonstration of the Modified Stillman's brushing technique using a soft toothbrush and fluoridated toothpaste twice daily. Participants will be monitored for 90 days to assess changes in renal biomarkers (serum creatinine, blood urea nitrogen, and eGFR)",[13],"Procedure: scaling and root planning",{"label":15,"type":16,"description":17,"interventionNames":18},"Control - Oral Hygiene Instructions with Delayed Periodontal Therapy","ACTIVE_COMPARATOR","Participants in the control arm will receive only standardized oral hygiene instructions at baseline and will not undergo scaling and root planing during the 90-day study period. After completion of follow-up assessments, they will receive the same periodontal therapy as the intervention group (delayed therapy) to ensure ethical equivalence",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","scaling and root planning","Intervention 1: Scaling and Root Planing (SRP) + Oral Hygiene Instructions (OHI)\n\nIntervention Description:\n\nParticipants assigned to the intervention arm will receive full-mouth non-surgical periodontal therapy consisting of scaling and root planning (SRP). Ultrasonic scalers will be used to remove supragingival plaque and calculus, followed by hand instruments (curettes and scalers) for subgingival debridement and root planing. The procedure is performed in a single session by trained and calibrated dental hygienists. Participants will also receive standardized oral hygiene instructions (OHI), including demonstration of the Modified Stillman's toothbrushing technique using a soft-bristle toothbrush and fluoridated toothpaste twice daily. Each participant will be provided with an oral hygiene kit to ensure consistency. Postoperative care includes warm saline rinses for three days. No further periodontal treatment will be given during the 90-day follow-up period.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Muhammad Ather Khan, BDS","CONTACT","+92-333-2685579","+92-2199232660","ather.khan@duhs.edu.pk",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"Dow University of Health Scinces","RECRUITING","Karachi","Sindh","75330","Pakistan","PK",{"type":43,"coordinates":44},"Point",[45,46],67.0104,24.8608,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dr. Muhammad Ather Khan","Doctor","100612671","non-surgical-periodontal-therapy-and-kidney-outcomes-in-type-2-diabetes-mellitus-100612671",false,"NCT07256613","Non-surgical Periodontal Therapy and Kidney Outcomes in Type 2 Diabetes Mellitus","Outcomes of Non-surgical Periodontal Therapy on Urea and Creatinine Levels in Type-2 Diabetes Mellitus Patients","KIDPER","Inclusion Criteria:\n\nAdults between 30 and 65 years of age.\n\nMen and women previously diagnosed with type 2 diabetes mellitus for at least one year.\n\nParticipants with uncontrolled diabetes, defined as HbA1c ≥ 7%.\n\nPresence of moderate to severe gum disease (Stage II or Stage III periodontitis) as determined by a dental examination.\n\nEstimated glomerular filtration rate (eGFR) of 60 mL\u002Fmin\u002F1.73 m² or higher.\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\nCritically ill individuals or those unable to communicate effectively.\n\nPregnant or breastfeeding women.\n\nWomen currently using hormone replacement therapy or oral contraceptives within the past six months.\n\nIndividuals taking steroidal, nonsteroidal anti-inflammatory drugs (NSAIDs), or other anti-inflammatory medications within the past three months (except low-dose aspirin up to 75 mg daily).\n\nParticipants with a recent history of major blood loss, trauma, or gastrointestinal bleeding.\n\nUse of antibiotics within the last month.\n\nHistory of fever or vomiting lasting more than one week within the last month.\n\nRegular tobacco or alcohol users.\n\nIndividuals with any other chronic disease or condition that could interfere with study outcomes.\n\nIndividuals unwilling or unable to comply with study procedures or follow-up visits.","ALL","30 Years","65 Years",{"count":64,"type":65},46,"ESTIMATED","INTERVENTIONAL",[68],"NA","Brief Summary (Lay Description)\n\nThis research study is being conducted to understand whether treating gum disease (periodontitis) can help improve kidney health in patients who have type-2 diabetes mellitus (T2DM). Both diabetes and gum disease are common long-term conditions that often occur together. People with uncontrolled diabetes are at risk of developing kidney problems due to damage in the small blood vessels of the kidneys - a condition known as diabetic nephropathy.\n\nScientific evidence has already shown that treating gum disease can help improve blood sugar control in diabetic patients. However, it is still unclear whether gum treatment can also help reduce the risk or severity of kidney-related complications. This study aims to find out if non-surgical periodontal therapy (NSPT), which includes scaling and root planing (deep dental cleaning), has any effect on blood markers of kidney function - specifically urea, creatinine, and estimated glomerular filtration rate (eGFR) - in patients with uncontrolled type-2 diabetes.\n\nThe study will be conducted as a randomized controlled trial involving 46 patients with uncontrolled T2DM (HbA1c ≥ 7%) who also have moderate to severe gum disease. Participants will be divided randomly into two groups:\n\nTest Group: Will receive full-mouth non-surgical periodontal therapy (scaling and root planing) and oral hygiene instructions.\n\nControl Group: Will receive oral hygiene instructions only and will get the same gum treatment later (after 90 days, as delayed therapy).\n\nAll participants will have their gum health examined, and blood tests will be done at the start and again after 90 days to measure urea, creatinine, and eGFR levels. These tests help determine how well the kidneys are working. The changes in these values before and after gum treatment will show whether improving oral health has any beneficial impact on kidney function in diabetics.\n\nThe study is expected to take one year and will be conducted at Dow University of Health Sciences, Karachi. All participants will receive standard dental and laboratory assessments at no cost. The results may help improve future strategies for managing diabetic patients by integrating oral health care with medical care.\n\nPurpose:\n\nTo determine whether treating gum disease (through non-surgical periodontal therapy) can improve kidney function markers - urea, creatinine, and eGFR - in patients with uncontrolled type-2 diabetes mellitus.\n\nQuestion being answered:\n\nDoes non-surgical periodontal therapy have a positive effect on kidney function in uncontrolled type-2 diabetic patients by reducing urea and creatinine levels and improving eGFR?",[71,72,73],"Type 2 Diabetes Mellitus MeSH:D003924","Periodontitis MeSH:D010518","Diabetic Nephropathies MeSH:D003928",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Type 2 Diabetes Mellitus","Uncontrolled Type 2 Diabetes","Diabetes-related nephropathy","Chronic kidney disease (CKD)","Diabetic nephropathy","periodontitis","non surgical periodontal therapy","scaling","root palnning","serum creatinine","blood urea nitrogen","BUN","eGFR","MDRD GFR euation","oral hygiene instruction(OHI)","Randomised control trial","2025-11-20",{"date":93,"type":94},"2025-12-01","ACTUAL",{"date":96,"type":94},"2025-08-15",{"date":98,"type":65},"2026-04-15",{"name":5,"class":6},1]