Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT02981693
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2016-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2016-11-27', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographical assessments', 'timeFrame': '1 year after root canal therapy', 'description': 'The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".'}], 'secondaryOutcomes': [{'measure': 'Clinical assessments', 'timeFrame': '1 year after root canal therapy', 'description': 'The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.'}, {'measure': 'Postoperative Pain Evaluation', 'timeFrame': '1 week after root canal therapy', 'description': 'Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.'}]}, 'conditionsModule': {'conditions': ['Irreversible Pulpitis', 'Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P \\< 0.05 was conducted to measure difference between the arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects were required to:\n\n1. have a mature tooth with closed apices;\n2. have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;\n3. be prepared to appear for follow-up and\n4. sign informed consent form.\n\nExclusion Criteria:\n\nSubjects with:\n\n1. moderate or severe marginal periodontitis;\n2. internal or external root resorption in periapical radiograph;\n3. active systemic disease;\n4. physical or mental disability,\n5. pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02981693', 'briefTitle': 'Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'The Dental Hospital of Zhejiang University School of Medicine'}, 'officialTitle': '1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'DHZhejiangU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iRoot SP sealer', 'description': 'iRoot SP sealer was used as root canal sealer in root canal obturation.', 'interventionNames': ['Procedure: Root canal sealer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AH Plus sealer', 'description': 'AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.', 'interventionNames': ['Procedure: Root canal sealer']}], 'interventions': [{'name': 'Root canal sealer', 'type': 'PROCEDURE', 'description': 'Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.', 'armGroupLabels': ['AH Plus sealer', 'iRoot SP sealer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hui Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hui Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hui Chen', 'investigatorAffiliation': 'The Dental Hospital of Zhejiang University School of Medicine'}}}}