Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108559
• Other study ID #: NEU4
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: December 19, 2019

Study information

• Verified date: August 2019
• Source: Konya Necmettin Erbakan Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 19, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• 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.
• 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.

Other:
• Control Group
Routine third molar extraction will be performed. No extra procedures will be done after surgery.

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Konya	Karatay

Sponsors (1)

Lead Sponsor	Collaborator
Konya Necmettin Erbakan Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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