Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT03724266
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D048271', 'term': 'Chitosan'}, {'id': 'D002126', 'term': 'Calcium Hydroxide'}], 'ancestors': [{'id': 'D002686', 'term': 'Chitin'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participants should be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'postoperative pain after intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in postoperative pain after intervention of chitosan: NRS', 'timeFrame': '4,12,24,27 hours', 'description': 'pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours'}], 'secondaryOutcomes': [{'measure': 'change in healing of apical periodontitis', 'timeFrame': '3,6,12 months', 'description': 'linear measurment of apical radiolucency using cone beam computed tomography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Healing']}, 'descriptionModule': {'briefSummary': 'Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing', 'detailedDescription': 'PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).\n\nI (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.\n\nO (outcome):\n\nPrimary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours\n\nSecondary outcome:\n\n1. Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months\n2. Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.\n3. healing of apical periodontitis using CBCT at 3, 6, 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients in good general health.\n* Patient's age ranging between 20-40 years with no sex predilection.\n* Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.\n* Evidence of apical radiolucency (minimum size 2 mm x 2 mm).\n* Patients' acceptance to participate in the study.\n\nExclusion criteria:\n\n* Medically compromised patients with a severe systemic condition.\n* Pregnant female patients.\n* Patients who had taken any antibiotic or analgesics during the past 24 hours.\n* Presence of a swelling because emergency management may include incision and drainage.\n* Retreatment cases.\n* Generalized periodontitis (calculus, deep pockets).\n* Out of normal variations (open apex- severely curved canal- obstructed canal)."}, 'identificationModule': {'nctId': 'NCT03724266', 'briefTitle': 'Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing', 'orgStudyIdInfo': {'id': 'ahmed abdelmonam'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chitosan', 'description': 'chitosan as intracanal medication 0.2% in form of gel', 'interventionNames': ['Drug: Chitosan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'calcium hydroxide', 'description': 'intracanal medication', 'interventionNames': ['Drug: Calcium Hydroxide']}], 'interventions': [{'name': 'Chitosan', 'type': 'DRUG', 'description': 'chitosan will be used as intracanal medication', 'armGroupLabels': ['chitosan']}, {'name': 'Calcium Hydroxide', 'type': 'DRUG', 'otherNames': ['CaOH'], 'description': 'intracanal medication', 'armGroupLabels': ['calcium hydroxide']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd student, principle investigator', 'investigatorFullName': 'ahmed abdelmonam abd elmougoud', 'investigatorAffiliation': 'Cairo University'}}}}