Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT05543434
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Hyaluronic Acid in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level gain', 'timeFrame': '3 months', 'description': 'Clinical attachment gain by using UNC15 Periodontal probe/ numerical data'}], 'secondaryOutcomes': [{'measure': 'Pocket depth reduction', 'timeFrame': '3 moths', 'description': 'Pocket depth reduction by using UNC15 Periodontal probe/ numerical data'}, {'measure': 'Bleeding on probing', 'timeFrame': '3 months', 'description': 'Bleeding on probing by using UNC15 Periodontal probe/ binary data'}, {'measure': 'Gingival Recession', 'timeFrame': '3 months', 'description': 'Gingival Recession by using UNC15 Periodontal probe/ numerical data'}, {'measure': 'Radiographic Evaluation', 'timeFrame': '3 months', 'description': 'by using periapical radiograph with standardized acrylic stent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '40665270', 'type': 'DERIVED', 'citation': 'Al-Abbadi R, Shemais N, Nawwar A, Fawzy El-Sayed KM. Non-surgical periodontal therapy with and without hyaluronic acid gel in type 2 diabetic stage-II periodontitis patients: a randomized clinical trial. BMC Oral Health. 2025 Jul 15;25(1):1166. doi: 10.1186/s12903-025-06485-2.'}]}, 'descriptionModule': {'briefSummary': 'sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.', 'detailedDescription': 'To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patient with controlled diabetic type 2 (HgA1C \\<7) (Mori et al., 2021).\n* Periodontitis stage II.\n* Periodontitis grade B.\n* Pocket depth \\> 4 mm.\n* Smoking ≤ 10 cigarettes/day.\n* Cooperative patients able and accept to come for follow up appointments\n\nExclusion Criteria:\n\n* • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.\n\n * Having surgical therapy or undergoing orthodontic treatment.\n * Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.\n * Pregnant and lactation females.\n * Smoking ˃ 10 cigarettes/day.\n * Patients with poor oral hygiene.\n * Any known allergies'}, 'identificationModule': {'nctId': 'NCT05543434', 'briefTitle': 'Application of Hyaluronic Acid in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel', 'orgStudyIdInfo': {'id': 'Reem'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyaluronic acid', 'description': 'Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after.', 'interventionNames': ['Drug: Hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'scaling and root planing', 'description': 'scaling and root planing using ultrasonic scaler and hand instruments.', 'interventionNames': ['Drug: Hyaluronic acid']}], 'interventions': [{'name': 'Hyaluronic acid', 'type': 'DRUG', 'otherNames': ['Gingigel /Germany'], 'description': 'anti-inflammatory, anti-edematous, osseoinductive.', 'armGroupLabels': ['hyaluronic acid', 'scaling and root planing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nesma M Shemais, PHD', 'role': 'CONTACT', 'email': 'nesma.shemais@dentistry.cu.edu.eg', 'phone': '00201005615697'}], 'facility': 'faculty of dentistry Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Reem M Alabbadi, BDS', 'role': 'CONTACT', 'email': 'reem.alabbadi@dentistry.cu.edu.eg', 'phone': '00201551563633'}, {'name': 'Nesma M Shemais, PHD', 'role': 'CONTACT', 'email': 'nesma.shemais@dentistry.cu.edu.eg', 'phone': '00201005615697'}], 'overallOfficials': [{'name': 'Reem M Alabbadi, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'master student'}, {'name': 'Nesma M Shemais, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University'}, {'name': 'Karim F Elsayed, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dentist', 'investigatorFullName': 'Reem Mohammed Ahmed Al-abbadi', 'investigatorAffiliation': 'Cairo University'}}}}