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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04740450
Other study ID # KT tape imp
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date July 15, 2021

Study information

Verified date August 2021
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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. Kinesio 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. Many 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 15, 2021
Est. primary completion date June 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Age > 18 years, with no systemic disease(s) Bilateral impacted mandibular third molar class II position B on Pell- Gregory classification. Exclusion Criteria: - Patients that had any local infection, tobacco use, oral contraceptive, pregnancy, lactation. - sensitivity to the tapes - reluctance to shave facial hair (for men) - known allergies to medication administered in the study,

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesio taping
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
Wound Tape
skin colored wound tape tapped in technique described by Gozluklu et al in 2020

Locations

Country Name City State
Egypt Faculty of Dentistry Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Gözlüklü Ö, Ulu M, Gözlüklü HÖ, 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. — View 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). pii: E3988. doi: 10.3390/jcm9123988. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative swelling 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. one week
Secondary pain VAS measure one week
Secondary Preoperative and postoperative mouth opening measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper. one week
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