Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-31 @ 11:44 PM
Study NCT ID:
NCT07048028
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D003790', 'term': 'Dental Pulp Necrosis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012973', 'term': 'Sodium Hypochlorite'}], 'ancestors': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intracanal Bacterial Load', 'timeFrame': 'Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"', 'description': 'Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis', 'Dental Pulp Necrosis', 'Root Canal Infection']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn which of three common root-canal rinsing (irrigation) methods removes bacteria most effectively in adult patients who need root-canal treatment. The main questions it will answer are:\n\nHow much does a chitosan solution used alone lower the number of bacteria inside the root canal? Do the combinations sodium hypochlorite + chitosan or sodium hypochlorite + EDTA lower bacteria even more than chitosan alone? Researchers will compare the three irrigation methods to see which one achieves the greatest bacterial reduction.\n\nWhat participants will do\n\nBe randomly assigned to one of three groups:\n\nGroup 1: Chitosan only Group 2: Sodium hypochlorite followed by chitosan Group 3: Sodium hypochlorite followed by EDTA\n\nAttend two clinic visits:\n\nVisit 1:\n\nReceive standard root-canal treatment under local anesthesia. Provide tiny paper-point samples from inside the canal before and after the assigned rinse (painless; takes seconds).\n\nVisit 2 (about 1 week later):\n\nReturn for a check-up and final filling of the tooth. Record any pain or discomfort for the first three days after treatment in a simple diary (or by phone).\n\nAbout 90 adults will take part. All procedures are routine in dental care, and there is no cost to participate. Participants may withdraw at any time and can ask the study dentist any questions throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who agreed to participate in the study\n* Systemically healthy patient\n* Mandibular premolar teeth\n* Teeth that respond negatively to thermal tests and EPT\n* Patients who have not used antibiotics for at least 2 weeks\n\nExclusion Criteria:\n\n* Teeth with previous primary root-canal treatment\n* Pregnant patients\n* Severely curved roots (\\>25° curvature)\n* Canals with instrument separation during preparation\n* Calcified (obliterated) canals'}, 'identificationModule': {'nctId': 'NCT07048028', 'acronym': 'CHITO-PRE RCT', 'briefTitle': 'Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2025000117-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chitosan irrigation', 'description': 'Root canal irrigated with 0.2 % chitosan.', 'interventionNames': ['Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)']}, {'type': 'EXPERIMENTAL', 'label': 'NaOCl and Chitosan irrigation', 'description': 'Root canal irrigated with 10 mL of 2.5 % sodium hypochlorite (60 s contact), followed by 10 mL of 0.2 % chitosan solution (60 s contact). Final flush with 5 mL sterile saline', 'interventionNames': ['Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)', 'Drug: Sodium Hypochlorite']}, {'type': 'EXPERIMENTAL', 'label': 'NaOCl and EDTA irrigation', 'description': 'Root canal irrigated with 10 mL of 2.5 % sodium hypochlorite (60 s contact), followed by 10 mL of 17 % EDTA solution (60 s contact). Final flush with 5 mL sterile saline.', 'interventionNames': ['Drug: Sodium Hypochlorite', 'Drug: EDTA chelating agents']}], 'interventions': [{'name': 'Chitosan Low Molecular Weight (20-200 Mpa.S)', 'type': 'DRUG', 'description': 'A 0.2 % (w/v) low-molecular-weight chitosan solution (50-190 kDa, ≥75 % deacetylation) prepared fresh in 1 % acetic acid, pH ≈ 6.0. Ten mL is delivered into the root canal over 30 s and left in situ for an additional 30 s (total contact 60 s), followed by a 5 mL sterile saline flush', 'armGroupLabels': ['Chitosan irrigation', 'NaOCl and Chitosan irrigation']}, {'name': 'Sodium Hypochlorite', 'type': 'DRUG', 'description': 'Commercial 2.5 % (w/v) sodium hypochlorite endodontic irrigant. Ten mL is delivered over 30 s and left for 30 s (total contact 60 s), then flushed with 5 mL sterile saline', 'armGroupLabels': ['NaOCl and Chitosan irrigation', 'NaOCl and EDTA irrigation']}, {'name': 'EDTA chelating agents', 'type': 'DRUG', 'description': 'Ready-to-use 17 % EDTA solution (pH ≈ 7.3) for smear-layer removal. Ten mL is delivered over 30 s and left for 30 s (total contact 60 s), then flushed with 5 mL sterile saline', 'armGroupLabels': ['NaOCl and EDTA irrigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52200', 'city': 'Ordu', 'state': 'Altınordu', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Dagci, Research Assistant', 'role': 'CONTACT', 'email': 'dagci.esra.496@gmail.com', 'phone': '+905314275695'}], 'facility': 'Ordu University', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}], 'centralContacts': [{'name': 'Esra Dagci, Research Assistant', 'role': 'CONTACT', 'email': 'dagci.esra.496@gmail.com', 'phone': '+905314275695'}], 'overallOfficials': [{'name': 'Fatih Cakici, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 12 months after primary publication and ending 5 years after publication', 'ipdSharing': 'YES', 'description': 'De-identified participant-level log10 CFU/mL data (baseline and immediate post-instrumentation) will be available 12 months after publication. Researchers may request the dataset by emailing the Principal Investigator; a data-sharing agreement will be required.', 'accessCriteria': 'Access to the de-identified participant-level log10 CFU/mL dataset (baseline and immediate post-instrumentation) will be granted to qualified, non-commercial academic investigators.\n\nRequests must include a brief research proposal and proof of institutional ethics approval, and should be e-mailed to the Principal Investigator (dagci.esra.496@gmail.com). After approval and signature of a data-sharing agreement that prohibits re-identification or further redistribution, the dataset and data dictionary will be transferred via a secure, password-protected file-sharing service.\n\nNo clinical charts, radiographs, consent forms, or ethics-committee documents will be shared. Data will be available beginning 12 months after primary publication, with no end date.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ESRA DAĞCI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Esra Dagci', 'investigatorFullName': 'ESRA DAĞCI', 'investigatorAffiliation': 'Ordu University'}}}}