Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

NCT04108559 | Completed

• 1 other identifier: NEU4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Third Molar Tooth

Keywords

Kinesiology tape; Surgical drain; Pain; Swelling; Trismus

Outcome Measures

Primary Outcomes (3)

• Swelling will be assessed using paper ruler. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus.

  Swelling measurement will be done from the different three region on the face. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus. The swelling measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.

  Up to 1week

• Pain will be assessed using a visual analogue scale.

  The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done everyday in one week after the surgery.

  Up to 1week

• Trismus will be evaluated using a caliper at maximum mouth opening.

  Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.

  Up to 1week

Study Arms (3)

Kinesiologic Tape Group

EXPERIMENTAL

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.

Procedure: Kinesiologic Tape Group

Surgical Drain Group

EXPERIMENTAL

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.

Procedure: Drain Group

Control Group

PLACEBO COMPARATOR

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

Other: Control Group

Interventions

Kinesiologic Tape Group 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.

Kinesiologic Tape Group

Drain Group 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.

Surgical Drain Group

Control Group OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Alcohol abuse,
• Smoking,
• Pregnancy,
• No allergy
• Presence of acute severe periodontitis.

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Karatay, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Trismus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dilek Menziletoglu, Dr

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• Bozkurt Ku Isik, Prof Dr

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: August 26, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 19, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)