Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 5:33 AM
Study NCT ID:
NCT04740450
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative swelling', 'timeFrame': 'one week', 'description': 'Facial swelling was assessed by a three-line measurement method using a flexible plastic tape measure. The corresponding lines were tragus-alanasi (Tr-An; from the most posterior point of the tragus to the most lateral point of the ala nasi), tragus-commissure (Tr-Co; from the most posterior point of the tragus to the most lateral point of the lip commissure), and tragus-pogonion (Tr-Po; from the most posterior point of the tragus to the pogonion) distances. These measurements were performed with the patient sitting at 90° straight position with physiologic rest position of the mandible.'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': 'one week', 'description': 'VAS measure'}, {'measure': 'Preoperative and postoperative mouth opening', 'timeFrame': 'one week', 'description': 'measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impacted third molar', 'Kinesio taping', 'swelling'], 'conditions': ['Impacted Third Molar Tooth']}, 'referencesModule': {'references': [{'pmid': '32008990', 'type': 'BACKGROUND', 'citation': 'Gozluklu O, Ulu M, Gozluklu HO, Yilmaz N. Comparison of Different Kinesio Taping Techniques After Third Molar Surgery. J Oral Maxillofac Surg. 2020 May;78(5):695-704. doi: 10.1016/j.joms.2019.12.026. Epub 2020 Jan 7.'}, {'pmid': '33317073', 'type': 'BACKGROUND', 'citation': 'Jaron A, Jedlinski M, Grzywacz E, Mazur M, Trybek G. Kinesiology Taping as an Innovative Measure against Post-Operative Complications after Third Molar Extraction-Systematic Review. J Clin Med. 2020 Dec 9;9(12):3988. doi: 10.3390/jcm9123988.'}, {'pmid': '32667383', 'type': 'BACKGROUND', 'citation': 'Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively', 'detailedDescription': "Removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively.\n\nKinesio taping (KT), also termed ''elastic therapeutic bandage,'' is a popular technique used for the management of postoperative lymphedema after maxillofacial surgery. KT is an elastic therapeutic tape invented by Dr Kase in the 1970s. KT originated from sports medicine and is primarily used to support damaged soft tissues (muscles and joints), helping to reduce pain. KT is considered to regulate the blood and lymph flow and also to remove the congestion of lymphatic fluid or hemorrhage and, thus, has achieved popularity in the control of lymphedema.\n\nMany studies had evaluate the KT technique in reducing the morbidity after surgical removal of third molar. There is a lack of adequate evidence regarding effects of KT techniques versus placebo and the effectiveness of KT with that of other methods and medical agents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18 years, with no systemic disease(s) Bilateral impacted mandibular third molar class II position B on Pell- Gregory classification.\n\nExclusion Criteria:\n\n* Patients that had any local infection, tobacco use, oral contraceptive, pregnancy, lactation.\n* sensitivity to the tapes\n* reluctance to shave facial hair (for men)\n* known allergies to medication administered in the study,'}, 'identificationModule': {'nctId': 'NCT04740450', 'briefTitle': 'Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar Surgery: Randomized, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KT tape imp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study side', 'description': 'receive KT technique described by Gozluklu et al in 2020', 'interventionNames': ['Device: Kinesio taping']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control side', 'description': 'tapped with wound tape following the same technique', 'interventionNames': ['Device: Wound Tape']}], 'interventions': [{'name': 'Kinesio taping', 'type': 'DEVICE', 'description': 'skin colored Kinesio-Tex Gold tape, 50 mm \\_ 5 m (Kinesio Holding Corp, Albuquerque, NM) tapped in technique described by Gozluklu et al in 2020', 'armGroupLabels': ['study side']}, {'name': 'Wound Tape', 'type': 'DEVICE', 'description': 'skin colored wound tape tapped in technique described by Gozluklu et al in 2020', 'armGroupLabels': ['Control side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'Alshaimaa a Mohamed, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fayoum University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor in oral & maxillofacial Surgery Department', 'investigatorFullName': 'Alshaimaa Ahmed shabaan', 'investigatorAffiliation': 'Fayoum University'}}}}