Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-01-02 @ 10:43 AM
Study NCT ID:
NCT06373757
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival index', 'timeFrame': '6 months after treatment', 'description': 'Gingival index (GI) used for the assessment of prevalence and severity of gingivitis. A score from 0 to 3 is given to each area of the tooth.0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.\n\nIt was evaluated for every patient included in the study, 3 and at 6 months after treatment.'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': '6 months after treatment', 'description': 'Plaque index (PI) was used to assess oral hygiene where 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.\n\nIt was evaluated for every patient included in the study, 3 and at 6 months after treatment.'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months after treatment', 'description': 'Clinical attachment level (CAL) was evaluated for every patient included in the study, 3 and at 6 months after treatment.'}, {'measure': 'Periodontal probing depth', 'timeFrame': '6 months after treatment', 'description': 'Periodontal probing depth (PD) (referred to as pocket depth if periodontal disease is present) is the distance from the gingival margin to the apical portion of the gingival sulcus. Probing depths in healthy gingival sulci normally range from 1 to 3 mm.\n\nIt was evaluated for every patient included in the study, 3 and at 6 months after treatment.'}, {'measure': 'Acrylic stent for pocket assessment', 'timeFrame': '6 months after treatment', 'description': 'Acrylic stent for pocket assessment was evaluated for every patient included in the study, 3 and at 6 months after treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chitosan', 'Nano-hydroxyapatite Hydrogel', 'Intrabony Defect']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.', 'detailedDescription': 'Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.\n\nTreatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.\n\nChitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.\n\nHA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 25 to 55 years.\n* Both sexes.\n* Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.\n\nExclusion Criteria:\n\n* Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.\n* Smokers.\n* Pregnant and lactating females.\n* Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.'}, 'identificationModule': {'nctId': 'NCT06373757', 'briefTitle': 'Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'RECO6U/5-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (nano-HAP/Chitosan hydrogel):', 'description': 'The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.', 'interventionNames': ['Other: Nano-HAP/Chitosan hydrogel']}, {'type': 'NO_INTERVENTION', 'label': 'Group II', 'description': 'Patients were treated with supra and sub-gingival debridement only.'}], 'interventions': [{'name': 'Nano-HAP/Chitosan hydrogel', 'type': 'OTHER', 'description': 'The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.', 'armGroupLabels': ['Group I (nano-HAP/Chitosan hydrogel):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'country': 'Egypt', 'facility': 'October 6 University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt', 'investigatorFullName': 'Amany Ahmed Mohamed Alaraby', 'investigatorAffiliation': 'October 6 University'}}}}