Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT04740450
Collaborator
(none)
45
1
2
4
11.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Kinesio taping
  • Device: Wound Tape
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar Surgery: Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: study side

receive KT technique described by Gozluklu et al in 2020

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

Placebo Comparator: Control side

tapped with wound tape following the same technique

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

Outcome Measures

Primary Outcome Measures

  1. postoperative swelling [one week]

    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

  1. pain [one week]

    VAS measure

  2. Preoperative and postoperative mouth opening [one week]

    measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Fayoum Egypt 63514

Sponsors and Collaborators

  • Fayoum University

Investigators

  • Principal Investigator: Alshaimaa a Mohamed, phd, Fayoum University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University
ClinicalTrials.gov Identifier:
NCT04740450
Other Study ID Numbers:
  • KT tape imp
First Posted:
Feb 5, 2021
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alshaimaa Ahmed shabaan, associate professor in oral & maxillofacial Surgery Department, Fayoum University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021