Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07061756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nd:YAG Laser Effects on Subgingival Microbiota in Stage III-IV Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-16', 'size': 230470, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-30T06:38', 'hasProtocol': True}, {'date': '2024-08-16', 'size': 189026, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T06:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alpha diversity of subgingival microbiota', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The higher the alpha diversity, the greater the species richness and evenness of the microbial community.'}, {'measure': 'Probing Depth', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Probing depth (PD) measures the distance from the gingival margin to the base of the periodontal pocket, clinically assessing periodontal attachment loss and tissue destruction.'}], 'secondaryOutcomes': [{'measure': 'Beta diversity of subgingival microbiota', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Beta diversity reflects the similarity in species composition.'}, {'measure': 'Composition of subgingival microbiota', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The composition of subgingival microbiota refers to the taxonomic structure and relative abundance of bacterial species within the periodontal pocket biofilm, which plays a critical role in periodontal health and disease progression.'}, {'measure': 'Microbial phenotypes of subgingival microbiota', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The microbial phenotypes of subgingival microbiota encompass the functional and metabolic characteristics of periodontal biofilm communities, including virulence factors, antibiotic resistance profiles, and synergistic interactions that contribute to periodontal pathogenesis.'}, {'measure': 'Clinical Attachment Level (CAL)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Clinical Attachment Level (CAL) measures the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket, directly quantifying periodontal tissue destruction and tooth-supporting structure loss.'}, {'measure': 'Gingival Index (GI)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The Gingival Index (GI) assesses the severity of gingival inflammation through standardized scoring of redness, swelling, and bleeding tendency, providing a quantitative measure of periodontal tissue health.'}, {'measure': 'Plaque Index (PI)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The Plaque Index (PI) quantifies the extent of bacterial plaque accumulation on tooth surfaces, using standardized scoring systems to assess oral hygiene status and periodontal disease risk.'}, {'measure': 'Bleeding on Probing (BOP)', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Bleeding on Probing (BOP) evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. The study addresses two key questions: (1) Whether Nd:YAG laser combined with scaling and root planing (SRP) yields significantly greater improvements in periodontal parameters compared to SRP alone; and (2) How subgingival microbial dynamics correlate with therapeutic outcomes.\n\nParticipants were randomized into two groups: the SRP group (mechanical debridement only) and the Nd group (mechanical debridement with Nd:YAG laser therapy). Clinical parameters-including probing depth (PD), clinical attachment level (CAL), and gingival index (GI)-were assessed at baseline and 3 months post-treatment. Subgingival plaque samples were analyzed via 16S rDNA sequencing to characterize microbial community shifts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-80 years\n* Minimum of 14 remaining natural teeth\n* Diagnosis of Stage III-IV periodontitis according to the 2018 World Workshop classification system\n* No periodontal treatment within the past 6 months\n* Willing to provide informed consent and participate in the study protocol\n\nExclusion Criteria:\n\n* Presence of systemic conditions that may affect periodontal treatment outcomes (e.g., uncontrolled hypertension \\[\\>140/90 mmHg\\], diabetes mellitus \\[HbA1c \\>7%\\])\n* Use of antibiotics or medications known to induce gingival enlargement (e.g., calcium channel blockers, phenytoin) within the past 3 months\n* Coagulation disorders or hematologic diseases\n* Active systemic infections\n* Pregnancy or lactation\n* Acute periodontal lesions\n* Inability to comply with study protocols'}, 'identificationModule': {'nctId': 'NCT07061756', 'briefTitle': 'Nd:YAG Laser Effects on Subgingival Microbiota in Stage III-IV Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Characteristics of Subgingival Microbiota in Patients With Stage III-IV Periodontitis in Response to Nd:YAG Laser-Assisted Therapy', 'orgStudyIdInfo': {'id': '[2024]493-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nd group', 'description': 'The Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment.', 'interventionNames': ['Procedure: ND']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SRP group', 'description': 'The SRP group received standard periodontal therapy consisting of scaling and root planing (SRP) alone, serving as the active control for comparison against laser-assisted treatment.', 'interventionNames': ['Procedure: SRP']}], 'interventions': [{'name': 'SRP', 'type': 'PROCEDURE', 'description': 'Full-mouth scaling and root planing (SRP) was performed using an ultrasonic scaler (EMS AIR-FLOW MASTER PIEZON®) supplemented by Gracey curettes for subgingival instrumentation. All procedures were conducted under local anesthesia by a calibrated periodontist, with each quadrant treated for a minimum of 30 minutes. Patients received standardized oral hygiene instructions and were scheduled for a 3-month postoperative follow-up.', 'armGroupLabels': ['SRP group']}, {'name': 'ND', 'type': 'PROCEDURE', 'description': 'In addition to the identical SRP protocol described above, adjunctive Nd:YAG laser therapy (Wiser Waterlase MD, Vista Dental) was applied immediately post-SRP. Laser parameters were set at 150 mJ/pulse, 20 Hz frequency with water (level 1) and air (level 3) coolant. The fiber optic tip (300 μm diameter) was moved in a continuous "Zig-zag" pattern along the root surface and pocket epithelium, maintaining 2-second irradiation per site at a 30° angle to the tooth axis. Standardized oral hygiene instructions and 3-month follow-up were similarly provided.', 'armGroupLabels': ['Nd group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rui He', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Rui He', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}