Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

NCT ID: NCT04108559

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2019-12-19

Brief Summary

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The investigator's purpose was to compare the effects of the surgical drain and kinesiologic tape applications on postoperative morbidity after mandibular third molar surgery.

Detailed Description

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A total of 90 patients will be scheduled for impacted third molar surgery. The patients will be divided into 3 groups.All surgeries will be carried out by the same surgeon. Group A will be treated with kinesiologic tape, Group B will be treated with a surgical drainage tube and Group C will be control group. After surgery in control group, routine surgical extraction will be performed.The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

The duration of each procedure from the start of the incision to the time of last suture placement will be noted.

Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, visual analog scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face:

* Tragus-Pogonion
* Tragus-Labial Commissura
* Angulus Mandible-Lateral canthus

Maximum mouth opening will be noted before and after (one week later) the surgery.

Conditions

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Impacted Third Molar Tooth

Keywords

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Kinesiology tape Surgical drain Pain Swelling Trismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Kinesiologic Tape Group

After the routine impacted third molar surgery, the kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. Kinesiologic tape will be removed on the second postoperative day, and all sutures on will be removed on 7. postoperative day.

Group Type EXPERIMENTAL

Kinesiologic Tape Group

Intervention Type PROCEDURE

A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures.The kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. The patients will be invited after one week for removing the sutures.

Surgical Drain Group

After routine impacted third molar surgery, plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa.

Group Type EXPERIMENTAL

Drain Group

Intervention Type PROCEDURE

A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures. A plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa. The patients will be invited after one week for removing the sutures.

Control Group

Routine third molar extraction will be performed. No extra procedures will be done after surgery.

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

Routine third molar extraction will be performed. No extra procedures will be done after surgery.

Interventions

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Kinesiologic Tape Group

A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures.The kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. The patients will be invited after one week for removing the sutures.

Intervention Type PROCEDURE

Drain Group

A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures. A plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa. The patients will be invited after one week for removing the sutures.

Intervention Type PROCEDURE

Control Group

Routine third molar extraction will be performed. No extra procedures will be done after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older than 18 of age,
* Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B)
* Fully covered with mucosa and bone

Exclusion Criteria

* Alcohol abuse,
* Smoking,
* Pregnancy,
* No allergy
* Presence of acute severe periodontitis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Dilek Menziletoglu

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Menziletoglu, Dr

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Bozkurt Ku Isik, Prof Dr

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

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Necmettin Erbakan University

Konya, Karatay, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NEU4

Identifier Type: -

Identifier Source: org_study_id