Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 11:11 AM
Study NCT ID:
NCT04834466
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Pain Level Experience in Orthodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-04', 'size': 4291561, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-31T07:32', 'hasProtocol': True}, {'date': '2021-02-04', 'size': 1913743, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-04T14:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-04', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level difference within different orthodontic appliances', 'timeFrame': 'From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year', 'description': 'Orthodontic appliances such as Invisalign, conventional braces and self-ligated braces are included to compare. Pain assessed through visual analogue scale (VAS) rating 0(No pain) to 10(extreme pain) were given individually to participant with different orthodontic appliances to gather information. The lower the score, the lesser the pain and vise versa.'}], 'secondaryOutcomes': [{'measure': 'Pain level difference within different factors', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Factors such as gender, age, hygiene level, tooth discrepancies, habitude and mental state could affect the pain level experience during orthodontic treatment. Survey given with respective questions and pain assessed through visual analogue scale (VAS) rating 0(no pain) to 10(extreme pain) were given individually to participant to gather information. The lower the score, the lesser the pain and vise versa.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Pain', 'Pain', 'Orthodontic Appliance Complication']}, 'referencesModule': {'references': [{'pmid': '8921656', 'type': 'BACKGROUND', 'citation': 'Scheurer PA, Firestone AR, Burgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. doi: 10.1093/ejo/18.4.349.'}, {'pmid': '31956934', 'type': 'BACKGROUND', 'citation': 'Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. Pain level between clear aligners and fixed appliances: a systematic review. Prog Orthod. 2020 Jan 20;21(1):3. doi: 10.1186/s40510-019-0303-z.'}, {'pmid': '19852612', 'type': 'BACKGROUND', 'citation': 'Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1.'}, {'pmid': '29442079', 'type': 'BACKGROUND', 'citation': 'Banerjee S, Banerjee R, Shenoy U, Agarkar S, Bhattacharya S. Effect of orthodontic pain on quality of life of patients undergoing orthodontic treatment. Indian J Dent Res. 2018 Jan-Feb;29(1):4-9. doi: 10.4103/ijdr.IJDR_113_16.'}, {'pmid': '23132480', 'type': 'BACKGROUND', 'citation': 'Kafle D, Rajbhandari A. Anticipated pain and pain experience among orthodontic patients: is there any difference? Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):71-3. doi: 10.3126/kumj.v10i2.7348.'}, {'pmid': '32143365', 'type': 'BACKGROUND', 'citation': 'Nicotra C, Polizzi A, Zappala G, Leonida A, Indelicato F, Caccianiga G. A Comparative Assessment of Pain Caused by the Placement of Banded Orthodontic Appliances with and without Low-Level Laser Therapy: A Randomized Controlled Prospective Study. Dent J (Basel). 2020 Mar 4;8(1):24. doi: 10.3390/dj8010024.'}], 'seeAlsoLinks': [{'url': 'https://www.physio-pedia.com/Visual_Analogue_Scale', 'label': 'The Visual analogue Scale (VAS) for pain assessment'}, {'url': 'https://www.surveyhero.com', 'label': 'Questionnaire designed and distributed through this website'}]}, 'descriptionModule': {'briefSummary': 'Orthodontic pain has been the primary concern from all patients who requires orthodontic treatment. The design of the study will help us comprehend how patient experienced and managed pain during their orthodontic treatment, average pain level in different orthodontic appliances and factors that could affect pain level experience during treatment, including gender, age, brackets types, hygiene level and habitude.', 'detailedDescription': 'To interpret the average pain level experience in orthodontic treatment and find correlations of different pain level within each individual from the clinical reports and questionnaires collected from each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with orthodontic treatment over 2 months and less than 12 months\n* Patient with braces or Invisalign\n* Patient who goes to orthodontic visits routinely\n\nExclusion Criteria:\n\n* Patient undergoing orthopaedic treatment (Functional appliances, 2x4 braces placement, maxillary expansion)\n* Patient who do not understand Spanish\n* Patient with cognitive impairment\n* Patient who do not want to participate in the study\n* Patient who have complete their orthodontic treatment'}, 'identificationModule': {'nctId': 'NCT04834466', 'briefTitle': 'Factors Associated With Pain Level Experience in Orthodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Alfonso X El Sabio University'}, 'officialTitle': 'Factors Associated With Pain Level Experience in Orthodontic Treatment', 'orgStudyIdInfo': {'id': 'AlfonsoXElSabioU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pain Level experience during orthodontic treatment', 'type': 'BEHAVIORAL', 'description': 'A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28037', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia CINTORA LOPEZ', 'role': 'CONTACT', 'email': 'info@UAX.es', 'phone': '+34914402330'}], 'facility': 'Centro Odonologico Innovacion y Especilidades Avanzadas', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Chia Jung Lee', 'role': 'CONTACT', 'email': 'jody929lee2012@gmail.com', 'phone': '+34603745177'}], 'overallOfficials': [{'name': 'Chia Jung Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Alfonso X El Sabio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data could be shared for further analysis or comparison to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Jung Lee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shen Gaang Jong Shiaw Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Chia Jung Lee', 'investigatorAffiliation': 'Alfonso X El Sabio University'}}}}