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NCT Number: NCT04108559

Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

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.

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Key information

Conditions

Impacted Third Molar Tooth Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Karatay, 42050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Control Group

Other

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

Primary outcomes

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

    Time frame: Up to 1week

    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.

  2. Pain will be assessed using a visual analogue scale.

    Time frame: Up to 1week

    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.

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

    Time frame: Up to 1week

    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.

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape on Postoperative Pain, Swelling and Trismus in Impacted Mandibular Third Molar Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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