Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT01917604
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-01', 'size': 1935944, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-05-06T22:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2013-08-04', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral health based Quality of life (Annexure 1; page 1 and page 2)', 'timeFrame': 'pre-treatment and 1 month post treatment (average duration of treatment 18 months )', 'description': 'to evaluate change in Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both groups'}, {'measure': 'Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)', 'timeFrame': '24 hours after surgical exposure', 'description': 'Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups'}, {'measure': 'Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)', 'timeFrame': '10th day after surgical exposure', 'description': 'Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups'}, {'measure': 'Clinical outcomes - periodontal (Annexure 1; page 5)', 'timeFrame': 'Three month post debond', 'description': 'Periodontal outcomes of disimpacted canines accessed clinically and compared for both open and closed groups; contralateral canine of maxillary arch will be control group.'}, {'measure': 'Maxillary canine aesthetic index (Annexure 1; page 7)', 'timeFrame': 'one month after debond', 'description': 'comparision to control side with experimental side of both the groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open versus Closed surgical technique', 'Palatally impacted maxillary canine', 'Orthodontic disimpaction', 'Oral health related Quality of life'], 'conditions': ['Tooth, Impacted']}, 'referencesModule': {'references': [{'pmid': '22677328', 'type': 'RESULT', 'citation': 'Parkin NA, Deery C, Smith AM, Tinsley D, Sandler J, Benson PE. No difference in surgical outcomes between open and closed exposure of palatally displaced maxillary canines. J Oral Maxillofac Surg. 2012 Sep;70(9):2026-34. doi: 10.1016/j.joms.2012.02.028. Epub 2012 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.', 'detailedDescription': 'The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. The protocol has been approved by local ethics committee of Jamia Millia Islamia and all participants will be provided with an informed consent agreement. The settings will be the orthodontic department of a dental teaching hospital (Faculty of Dentistry, Jamia Millia Islamia). Participants for the trial will be identified from treatment waiting lists and new patient clinics.\n\nProper randomization procedures and reporting include the following steps.\n\n1. Generation of the random allocation sequence, including details of any restrictions.\n2. Allocation concealment.\n3. Implementation of the random allocation sequence:\n\ninformation on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.\n\nOPEN SURGICAL EXPOSURE\n\n* Surgically uncover the canine tooth followed by bone removal exposing the largest diameter of the ectopic canine crown. The edges need to be substantially trimmed back and dental follicle removed to prevent reclosure of the very thick palatal mucosa.\n* Surgical excision of the palatal mucosa-standardized using a preformed wire template.\n* Coe-pack surgical dressing (GC America Inc, Alsip, IL) will be left in place.\n* The patient will be reviewed 10 days later and the surgical pack removed and the bracket bonded and force application started once the tooth has erupted sufficiently for an orthodontic attachment to be glued onto its surface, orthodontic brace treatment is commenced to bring the tooth into line.\n\nCLOSED SURGICAL EXPOSURE\n\n• Surgically uncover the canine tooth and Surgical bone removal exposing the largest diameter of the ectopic canine crown.\n\n* An multipurpose attachment with ligature wire and e chain will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).\n* An orthodontic attachment (button) with ligature wire and bracket with closed coil spring will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).\n\nOutcome Assessment:\n\nThe following outcomes will be measured before, during and post orthodontic treatment:\n\nPrimary Outcome Measures:\n\n1. Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire pre-treatment and post treatment (one month after debond) -(Annexure 1 - page 1,2)\n2. Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire 24 hrs and 10 days after surgical caniine exposure (Annexure 1 - page 3,4).\n3. Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).\n4. Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment\n\n* Age 13-25 years Minimal orthodontic problems other than the ectopic canine\n* Good oral hygiene and motivated to wear fixed appliances for at least 2 years\n\nExclusion Criteria:\n\nCompromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)\n\n* Periodontal disease (bleeding on probing, pocket probing depths \\_3 mm and decreased bone levels as diagnosed from baseline panoramic imaging)\n* Cases in which the canine is to be brought into the position of the lateral incisor.'}, 'identificationModule': {'nctId': 'NCT01917604', 'briefTitle': 'Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction', 'organization': {'class': 'OTHER', 'fullName': 'Jamia Millia Islamia'}, 'officialTitle': 'Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'imc25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open exposure and control', 'description': '● surgically uncover the canine tooth and bone removal exposing the largest diameter of the ectopic canine crown make a window in the palatal soft tissue and bond bracket after 10 days', 'interventionNames': ['Procedure: open exposure']}, {'type': 'EXPERIMENTAL', 'label': 'closed exposure and control', 'description': 'raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap', 'interventionNames': ['Procedure: closed exposure']}], 'interventions': [{'name': 'open exposure', 'type': 'PROCEDURE', 'description': 'the open surgical methods of exposing the canine is compared with control', 'armGroupLabels': ['open exposure and control']}, {'name': 'closed exposure', 'type': 'PROCEDURE', 'description': 'closed exposure is compared with control', 'armGroupLabels': ['closed exposure and control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110025', 'city': 'Delhi', 'country': 'India', 'facility': 'Jamia Millia Islamia', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'panchali batra, m.d.s.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jamia Millia Islamia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jamia Millia Islamia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Council of Scientific and Industrial Research, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Orthodontics', 'investigatorFullName': 'DR.PANCHALI BATRA', 'investigatorAffiliation': 'Jamia Millia Islamia'}}}}