[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609482":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":41,"locations":31,"responsibleParty":47,"collaborators":31,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":31,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":82,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":31},{"fullName":5,"class":6},"Kafrelsheikh University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Control: Scaling and Root Planing (SRP) Only","ACTIVE_COMPARATOR","Participants receive conventional subgingival scaling and root planing (SRP) alone using hand and ultrasonic instruments, plus standardized oral hygiene instruction. No adjunctive local drug or gel is applied.",[13],"Procedure: Arm 1 Scaling and Root Planing (SRP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - Experimental: SRP + 1% Metformin Gel","EXPERIMENTAL","Participants receive conventional SRP followed by subgingival application of 1% metformin gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction.",[19],"Drug: Arm 2 Metformin Gel 1% (locally delivered)",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel","Participants receive conventional SRP followed by subgingival application of 0.2% chlorhexidine gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction.",[24],"Drug: Arm 3 Chlorhexidine Gel 0.2% (locally delivered)",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Arm 1 Scaling and Root Planing (SRP)","Full-mouth supragingival and subgingival debridement performed with ultrasonic and hand instruments (Gracey curettes). SRP performed to remove plaque and calculus and root-surface decontamination. Standardized oral hygiene instruction is provided after the procedure.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Arm 2 Metformin Gel 1% (locally delivered)","1% metformin hydrochloride formulated in a gellan-gum gel base (as per protocol). After SRP, gel is delivered subgingivally with a sterile syringe (23-gauge cannula) and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Gingival crevicular fluid sampling and clinical follow-up at 1, 3, and 6 months.",[15],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Arm 3 Chlorhexidine Gel 0.2% (locally delivered)","0.2% chlorhexidine digluconate gel prepared in carbopol base. After SRP, gel is delivered subgingivally with a sterile syringe and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Clinical follow-up at 1, 3, and 6 months.",[21],[42],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Duaa Luwai Hashim, B.D.S (2011) NRU","CONTACT","+20 10 96329474","Doaaloai09@gmail.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Duaa Luwai Osman Hashim","(B.D.S. 2011 ) NATIONAL RIBAT UNIVERSITY","100609482","metformin-versus-chlorhexidine-gel-as-adjuncts-to-scaling-and-root-planing-in-stage-ii-grade-b-periodontitis-100609482",false,"NCT07215156","Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis","Comparative Study Between Metformin and Chlorhexidine Gel as Adjunctive to Conventional Non-Surgical Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial","MET-CHX Perio","Inclusion Criteria:\n\nAdults aged 18-60 years.\n\nDiagnosis of Stage II, Grade B periodontitis.\n\nProbing pocket depths ≤ 5 mm with clinical attachment loss of 3-4 mm in selected sites.\n\nGenerally healthy individuals without systemic conditions affecting periodontal health.\n\nExclusion Criteria:\n\nCurrent smokers or users of tobacco products.\n\nPregnant or lactating women.\n\nKnown allergy to metformin or chlorhexidine.\n\nUse of antibiotics or anti-inflammatory drugs within the past 3 months.\n\nHistory of periodontal therapy within the past 6 months.","ALL","18 Years","60 Years",{"count":63,"type":64},60,"ESTIMATED","INTERVENTIONAL",[67],"NA","This clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Although SRP is the standard non-surgical treatment, it may not fully eliminate harmful bacteria or prevent disease recurrence.\n\nChlorhexidine is a widely used antimicrobial gel, while metformin, a medication commonly prescribed for diabetes, has shown anti-inflammatory and bone-supportive effects when used locally in the gums. This study will directly compare the effectiveness of 1% metformin gel and 0.2% chlorhexidine gel, both applied subgingivally after SRP, against SRP alone.\n\nSixty adult participants diagnosed with Stage II, Grade B periodontitis will be randomly assigned into three groups: SRP only (control), SRP plus metformin gel, and SRP plus chlorhexidine gel. Clinical outcomes (plaque index, gingival index, probing pocket depth, and clinical attachment level), inflammatory markers (MMP-8 in gingival crevicular fluid), and radiographic bone density will be measured at baseline, 1 month, 3 months, and 6 months.\n\nThe goal is to determine whether metformin gel or chlorhexidine gel provides superior improvements in periodontal healing when compared with SRP alone. Findings from this trial may guide evidence-based decisions on optimizing non-surgical periodontal therapy.",[70,71],"Stage II, Grade B Periodontitis","Chronic Periodontitis",[73,74,71,75,76,77,78,79,80,81],"Periodontitis","Stage II Grade B Periodontitis","Scaling and Root Planing (SRP)","Non-surgical Periodontal Therapy","Metformin Gel","Chlorhexidine Gel","Local Drug Delivery","Periodontal Regeneration","Inflammatory Markers (MMP-8)","NOT_YET_RECRUITING","2025-10-02",{"date":85,"type":86},"2025-10-10","ACTUAL",{"date":88,"type":64},"2025-10-06",{"date":90,"type":64},"2026-06-01",{"name":5,"class":6}]