Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 9:49 PM
Study NCT ID:
NCT06777303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing pocket depth reduction', 'timeFrame': '12 weeks', 'description': 'pocket depth is calculated using a UNC 15 perio probe to calculate the distance between the base of the pocket to the free gingival margin'}], 'secondaryOutcomes': [{'measure': 'plaque index', 'timeFrame': '12 weeks', 'description': 'according to Silness P. Loe H 1964'}, {'measure': 'clinical attachment gain', 'timeFrame': '12 weeks', 'description': 'measured from cemento-enemal junction to base of the pocket'}, {'measure': 'Gingival Bleeding Index', 'timeFrame': '12 weeks', 'description': 'according to Ainamo \\& Bay 1975'}, {'measure': 'o Total anti-oxidant capacity(T-AOC)', 'timeFrame': '12 weeks', 'description': 'laboratory investigation using Assay kit50T'}, {'measure': 'tumor necrosis factor alpha (TNF alpha)', 'timeFrame': '12 weeks', 'description': 'laboratory investigation using ELISA Kit (96T)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients\n\nMaterials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, The participants forty patients are classified into four groups:\n\n* Group1 : (-ve control group): SRP alone\n* Group2: (+ve control group): SRP+ chitosan Nano-particles\n* Group3: SRP + Curcumin-coated chitosan Nano-particles\n* Group4: SRP+ hyaluronic acid -coated chitosan Nano-particle\n\nAll Patients will undergo Phase I therapy, which includes scaling and root planing using ultrasonic tips and gracey curettes. Additionally, mechanical oral hygiene instructions will be provided, and participants will be advised to refrain from using any mouthwash throughout the duration of the study.\n\nFurthermore, patients within groups 2 to 4 will be subjected to an extra measure involving the application of the respective gel associated with their designated group. The gel will be administered on a weekly basis for duration of five weeks.\n\nClinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)). Laboratory assessment will be done at baseline and final assessment( after 3 months) . tess will be for antioxdiant levels and TNF alpha\n\n* Total anti-oxidant capacity(T-AOC) using Assay kit50T\n* TNF alpha using ELISA Kit (96T)', 'detailedDescription': 'Inclusion criteria:\n\nPatients who are systemically healthy Patient exhibiting periodontal pocket depths (PD) ≤5mm presence of clinical attachment loss (CAL) between 1-4mm cooperative individuals capable of adhering to mechanical oral hygiene instructions Patients who agreed on both written and verbal consent to participate in the study.\n\n6\n\no Exclusion criteria: patients with recent history of periodontal treatment (within the last 3 months) patients with recent use of antibiotic (within the past 3 months, pregnant or lactating women, individuals who are malnourished and taking vitamin supplements, Patients who regularly use mouthwashes.\n\nMethod of gel application: a blunt 2ml syringe will be used to administer the gel sub-gingivally until the pocket is filled\n\nCervicular fluid collection :\n\nThis is done at baseline and after 12 weeks\n\n* Insert absorbent paper points gently into the gingival crevice at the sulcus or pocket depth.\n* Allow the absorbent material to remain in the crevice for a specific duration (1 minute) to enable the collection of gingival crevicular fluid.\n* Carefully retrieve the paper points from the gingival crevice, ensuring that the collected fluid is preserved on the material.\n* Place the paper points in eppendorf tubes\n* Handle the samples with care to prevent contamination and promptly transport them to the laboratory for further analysis. If necessary, samples may undergo centrifugation to separate cells and debris from the fluid.\n\nPeriodontal assessment:\n\nThe following periodontal indices will be assessed at baseline, and after 12 weeks o Plaque Index according to Silness P. Loe H 1964\n\n* Gingival Bleeding Index/Bleeding On Probing(BOP) according to Ainamo \\& Bay 1975\n* Probing pocket depth (PPD) is measured from free gingival margin to base of the pocket.\n* Clinical attachment loss (CAL) is measured from cemento-enemal junction to base of the pocket.\n\nthe determination of the sample size was guided by reference of similar articles. . Employing G power for the calculation, the sample size was determined with a 0.676 effect size, a two-tailed test, α error set at 0.05, and a power of 0.8, resulting in a total calculated sample size of 10 individuals in each group.\n\nPretreatment period Participants were informed about the purpose of the study and screened for eligibility. They also were informed about the treatment received and the steps done, including non-surgical treatment and gel application with the associated risks, possible effects, and other treatment options available. The participants understood this explanation in broad terms according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. Additionally, they acknowledged that they would be required to attend the periodic recall visits and that they are legally competent to give written informed consent before performing any required steps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are systemically healthy\n* Patient exhibiting periodontal pocket depths (PD) ≤5mm\n* presence of clinical attachment loss (CAL) between 1-4mm\n* cooperative individuals capable of adhering to mechanical oral hygiene instructions\n* Patients who agreed on both written and verbal consent to participate in the study.\n\nExclusion Criteria:\n\n* patients with recent history of periodontal treatment (within the last 3 months)\n* patients with recent use of antibiotic (within the past 3 months)\n* pregnant or lactating women,\n* individuals who are malnourished and taking vitamin supplements,\n* Patients who regularly use mouthwashes.'}, 'identificationModule': {'nctId': 'NCT06777303', 'briefTitle': 'Efficacy of Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients', 'orgStudyIdInfo': {'id': 'A05010240M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1 (-ve control group) SRP alone', 'description': 'are treated with scaling and root planning alone', 'interventionNames': ['Procedure: scaling and root planning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2 ( +ve control group) SRP + chitosan nano-particles LDD', 'description': 'patients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery.', 'interventionNames': ['Drug: chitosan nano-particles']}, {'type': 'EXPERIMENTAL', 'label': 'group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles', 'description': 'patients are treated with SRP in addition to curcumin loaded on chitosan nano-particles as an adjunct local drug delivery.', 'interventionNames': ['Drug: curcurmin loaded on chitosan nano-particles']}, {'type': 'EXPERIMENTAL', 'label': 'group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles', 'description': 'patients are treated with SRP in addition to hyaluronic-acid loaded on chitosan nano-particles as an adjunct local drug delivery.', 'interventionNames': ['Drug: hyaluronic acid loaded on chitosan nano-particles']}], 'interventions': [{'name': 'curcurmin loaded on chitosan nano-particles', 'type': 'DRUG', 'description': 'the formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus', 'armGroupLabels': ['group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles']}, {'name': 'hyaluronic acid loaded on chitosan nano-particles', 'type': 'DRUG', 'description': 'the formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus', 'armGroupLabels': ['group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles']}, {'name': 'scaling and root planning', 'type': 'PROCEDURE', 'description': 'the -ve control group in the study', 'armGroupLabels': ['group 1 (-ve control group) SRP alone']}, {'name': 'chitosan nano-particles', 'type': 'DRUG', 'description': 'the +ve control group in the study', 'armGroupLabels': ['group 2 ( +ve control group) SRP + chitosan nano-particles LDD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}