NCT04740450

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

February 2, 2021

Last Update Submit

August 21, 2021

Conditions

Impacted Third Molar Tooth

Keywords

Impacted third molarKinesio tapingswelling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pain

    one week

  • Preoperative and postoperative mouth opening

    one week

Study Arms (2)

study side

EXPERIMENTAL

receive KT technique described by Gozluklu et al in 2020

Device: Kinesio taping

Control side

PLACEBO COMPARATOR

tapped with wound tape following the same technique

Device: Wound Tape

Interventions

Kinesio tapingDEVICE

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

study side
Wound TapeDEVICE

skin colored wound tape tapped in technique described by Gozluklu et al in 2020

Control side

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years, with no systemic disease(s) Bilateral impacted mandibular third molar class II position B on Pell- Gregory classification.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Fayyum, 63514, Egypt

Location

Related Publications (3)

  • 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: 32008990BACKGROUND

  • 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: 33317073BACKGROUND

  • 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.

    PMID: 32667383BACKGROUND

Study Officials

  • Alshaimaa a Mohamed, phd

    Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor in oral & maxillofacial Surgery Department

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

March 15, 2021

Primary Completion

June 20, 2021

Study Completion

July 15, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)