Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT07215156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blind design: participants are blinded to intervention allocation; clinicians applying treatment are aware of the group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: SRP alone, SRP + Metformin gel, or SRP + Chlorhexidine gel.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gingival Crevicular Fluid MMP-8 Levels', 'timeFrame': 'Baseline, 1 month, and 3 months', 'description': 'Active MMP-8 concentrations will be quantified in gingival crevicular fluid using ELISA. PerioPaper strips will be used for collection. Reduction in MMP-8 indicates decreased periodontal inflammation.'}, {'measure': 'Change in Clinical Attachment Level (CAL)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'CAL will be measured from the cementoenamel junction to the base of the periodontal pocket using a UNC-15 probe. Improvement in CAL reflects periodontal tissue healing and attachment gain.'}, {'measure': 'Change in Alveolar Bone Density', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Standardized periapical digital radiographs will be analyzed using Digora software to calculate mean gray-level values in the region of interest (1 mm below CEJ, 7 mm apically). An increase indicates bone density improvement.'}], 'secondaryOutcomes': [{'measure': 'Change in Probing Pocket Depth (PPD)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Probing depth will be measured at six sites per tooth using a UNC-15 probe. Reduction in pocket depth indicates clinical improvement in periodontal status.'}, {'measure': 'Change in Gingival Index (GI) Score', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Decreased GI score reflects reduction in gingival inflammation.'}, {'measure': 'Change in Plaque Index (PI) Score', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Oral hygiene status will be evaluated using the Silness and Löe Plaque Index. Reduction in PI indicates improved plaque control.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis', 'Stage II Grade B Periodontitis', 'Chronic Periodontitis', 'Scaling and Root Planing (SRP)', 'Non-surgical Periodontal Therapy', 'Metformin Gel', 'Chlorhexidine Gel', 'Local Drug Delivery', 'Periodontal Regeneration', 'Inflammatory Markers (MMP-8)'], 'conditions': ['Stage II, Grade B Periodontitis', 'Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a randomized, controlled, single-blind clinical trial conducted at the Department of Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology, Faculty of Dentistry, Kafrelsheikh University, Egypt. Sixty participants aged 18-60 years with Stage II, Grade B periodontitis will be enrolled. Participants will be randomly allocated (1:1:1) into three groups:\n\nGroup A (Control): SRP only\n\nGroup B (Test 1): SRP + 1% Metformin Gel\n\nGroup C (Test 2): SRP + 0.2% Chlorhexidine Gel\n\nSubgingival gels will be applied after SRP using sterile syringes, followed by periodontal pack placement for one week. All patients will receive standardized oral hygiene instructions.\n\nOutcome Measures:\n\nPrimary Outcomes: Clinical attachment level (CAL) changes, reduction in inflammatory markers (MMP-8), and radiographic bone density gain.\n\nSecondary Outcomes: Probing pocket depth (PPD), plaque index (PI), and gingival index (GI).\n\nFollow-up assessments will be performed at 1, 3, and 6 months. Data will be statistically analyzed using ANOVA and paired t-tests, with significance at p \\< 0.05.\n\nThe trial has been reviewed and approved by the Scientific Research Ethics Committee, Faculty of Dentistry, Kafrelsheikh University (Approval No. KFSIRB200-564, dated 24 February 2025).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07215156', 'acronym': 'MET-CHX Perio', 'briefTitle': 'Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KFSIRB200-564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 - Control: Scaling and Root Planing (SRP) Only', 'description': '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.', 'interventionNames': ['Procedure: Arm 1 Scaling and Root Planing (SRP)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Experimental: SRP + 1% Metformin Gel', 'description': '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.', 'interventionNames': ['Drug: Arm 2 Metformin Gel 1% (locally delivered)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel', 'description': '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.', 'interventionNames': ['Drug: Arm 3 Chlorhexidine Gel 0.2% (locally delivered)']}], 'interventions': [{'name': 'Arm 1 Scaling and Root Planing (SRP)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Arm 1 - Control: Scaling and Root Planing (SRP) Only']}, {'name': 'Arm 2 Metformin Gel 1% (locally delivered)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm 2 - Experimental: SRP + 1% Metformin Gel']}, {'name': 'Arm 3 Chlorhexidine Gel 0.2% (locally delivered)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Duaa Luwai Hashim, B.D.S (2011) NRU', 'role': 'CONTACT', 'email': 'Doaaloai09@gmail.com', 'phone': '+20 10 96329474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '(B.D.S. 2011 ) NATIONAL RIBAT UNIVERSITY', 'investigatorFullName': 'Duaa Luwai Osman Hashim', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}