Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06016894
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}], 'ancestors': [{'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recession height', 'timeFrame': '6 months', 'description': 'measurement recession height'}, {'measure': 'Recession width', 'timeFrame': '6 months', 'description': 'measurement of Recession width'}, {'measure': 'Height of the keratinized tissue', 'timeFrame': '6 months', 'description': 'measurement of Height of the keratinized tissue'}, {'measure': 'Percentage of root coverage', 'timeFrame': '6 months', 'description': 'It is calculated after 1, 3, 6 months as \\[RH preoperative - RH postoperative\\]/RH preoperative) x 100%.'}, {'measure': 'Radiographic assessment', 'timeFrame': '6 months', 'description': 'measurement of buccal bone gain'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': '6 months', 'description': 'measurement of Probing pocket depth'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'measurement of Clinical attachment level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': "The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.", 'detailedDescription': "gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP) is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is one of the most popular and effective artificial bone substitutes. It is osteoinductive as well as osteoconductive. These characteristics enable full bone defects regeneration together with its cell-mediated resorption. In this study, we compared between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with good systemic health and no contraindication for periodontal surgery.\n* Patients who are able to maintain good oral hygiene.\n* Gingival thickness for the site selected should be ≥1mm.\n* The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).\n\nExclusion Criteria:\n\n* Active infectious diseases (hepatitis, tuberculosis, HIV, etc….).\n* Medically compromised patients.\n* Patients taking medications known to cause gingival enlargement.\n* Pregnant patients and smokers.\n* Previous mucogingival surgery at the defect.\n* Restorations or caries in the area to be treated and non vital tooth.\n* Teeth which are tilted or rotated.'}, 'identificationModule': {'nctId': 'NCT06016894', 'briefTitle': 'Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession', 'orgStudyIdInfo': {'id': 'khafrelsheikh university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nanocrystalline hydroxyapatite', 'description': 'Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap', 'interventionNames': ['Procedure: coronally advanced flap', 'Other: Nanocrystalline hydroxyapatite loaded in PRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nanocrystalline tricalcium phosphate (NcTCP)', 'description': 'Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap', 'interventionNames': ['Procedure: coronally advanced flap', 'Other: Nanocrystalline tricalcium phosphate loaded in PRF']}], 'interventions': [{'name': 'coronally advanced flap', 'type': 'PROCEDURE', 'description': 'coronally advanced flap operation', 'armGroupLabels': ['Nanocrystalline hydroxyapatite', 'Nanocrystalline tricalcium phosphate (NcTCP)']}, {'name': 'Nanocrystalline hydroxyapatite loaded in PRF', 'type': 'OTHER', 'description': 'Nanocrystalline hydroxyapatite loaded in PRF', 'armGroupLabels': ['Nanocrystalline hydroxyapatite']}, {'name': 'Nanocrystalline tricalcium phosphate loaded in PRF', 'type': 'OTHER', 'description': 'Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF', 'armGroupLabels': ['Nanocrystalline tricalcium phosphate (NcTCP)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Oral Medicine and Periodontology', 'investigatorFullName': 'Enas Elgendy', 'investigatorAffiliation': 'October 6 University'}}}}