Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Kinesio taping
Wound Tape
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring Impacted third molar, Kinesio taping, swelling
Eligibility Criteria
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,
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
study side
Control side
Arm Description
receive KT technique described by Gozluklu et al in 2020
tapped with wound tape following the same technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
pain
VAS measure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04740450
Brief Title
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar
Official Title
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar Surgery: Randomized, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
Impacted third molar, Kinesio taping, swelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study side
Arm Type
Experimental
Arm Description
receive KT technique described by Gozluklu et al in 2020
Arm Title
Control side
Arm Type
Placebo Comparator
Arm Description
tapped with wound tape following the same technique
Intervention Type
Device
Intervention Name(s)
Kinesio taping
Intervention 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
Intervention Type
Device
Intervention Name(s)
Wound Tape
Intervention Description
skin colored wound tape tapped in technique described by Gozluklu et al in 2020
Primary Outcome Measure Information:
Title
postoperative swelling
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
pain
Description
VAS measure
Time Frame
one week
Title
Preoperative and postoperative mouth opening
Description
measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper.
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa a Mohamed, phd
Organizational Affiliation
Fayoum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Fayoum
ZIP/Postal Code
63514
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32008990
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.
Results Reference
background
PubMed Identifier
33317073
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.
Results Reference
background
PubMed Identifier
32667383
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.
Results Reference
background
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Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar
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