Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06574802
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Er:YAG Laser and Air Polishing Application in Periodontal Treatment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in PD', 'timeFrame': 'at 3 months, 6 months, 1 year, and 2 years', 'description': 'Changes in probing depth (PD) measured using periodontal probing'}, {'measure': 'Changes in CAL', 'timeFrame': 'at 3 months, 6 months, 1 year, and 2 years', 'description': 'Changes in clinical attachment level (CAL) measured using periodontal probing'}], 'secondaryOutcomes': [{'measure': 'changes in BI', 'timeFrame': 'at 3 months, 6 months, 1 year, and 2 years', 'description': 'Changes in bleeding index (BI) measured using periodontal probing'}, {'measure': 'PLI', 'timeFrame': 'at 3 months, 6 months, 1 year, and 2 years', 'description': 'Plaque index (PLI) assessed by an examiner using a scale of 0 to 3'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['generalized, stage Ⅱ or stage Ⅲ'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.', 'detailedDescription': 'The study will use a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus sub-gingival air polishing treatment, while the quadrants in the control group received ERL only. Clinical periodontal examinations were evaluated at baseline, 3 months, 6 months, 1 year, and 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) aged 35-65 years old, in good systemic healthy;\n* 2\\) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;\n* 3\\) a minimum of 20 teeth\n\nExclusion Criteria:\n\n* 1\\) pregnancy or recent pregnancy plans;\n* 2\\) had received periodontal treatment within the previous 6 months;\n* 3\\) taken antibiotics within the previous 3 months;\n* 4\\) had diabetes;\n* 5\\) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.'}, 'identificationModule': {'nctId': 'NCT06574802', 'briefTitle': 'Er:YAG Laser and Air Polishing Application in Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Combined Application of Er:YAG Laser and Sub-gingival Air Polishing Powder in Treatment of Periodontitis: A Split-mouth, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CYFH202207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'test group', 'description': 'Er:YAG laser (ERL) plus sub-gingival air polishing treatment', 'interventionNames': ['Procedure: ERL + air polishing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'ERL treatment only', 'interventionNames': ['Procedure: ERL']}], 'interventions': [{'name': 'ERL + air polishing', 'type': 'PROCEDURE', 'description': 'Er:YAG laser (ERL) plus sub-gingival air polishing treatment', 'armGroupLabels': ['test group']}, {'name': 'ERL', 'type': 'PROCEDURE', 'description': 'ERL treatment', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuan Zhou, Dr.', 'role': 'CONTACT'}], 'facility': 'Beijing Chao Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xuan Zhou, Doctor', 'role': 'CONTACT', 'email': 'xuanzhou@sina.com', 'phone': '86-10-85231344'}], 'overallOfficials': [{'name': 'GuangXu Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}