Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.

The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Other: Edema measurement methods

Detailed Description

The patients will be selected among the patients who apply for mandibular impacted third molar extraction to Necmettin Erbakan University, Faculty of Dentistry. A total of 60 patients will be included. All third molar operations will be carried out by the same surgeon in all groups with the same technique.Two methods will be used to evaluate the edema on the face.

1. Method The surgeon will measure from three different places on the patient's face ( two point distance) with the help of a paper ruler.

   • Tragus-Pogonion
   • Tragus-Labial Komissura
   • Angulus Mandibula-Lateral Kantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.
2. Method Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 4 will be pointed on the scale postoperative 2. and 7. days.

A correlation between the results of the first and second methods will be examined.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey, 42050
      • Necmettin Erbakan University, Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion)
• Patients with any chronic disease and allergy

Exclusion Criteria:

• Smoking
• Pregnancy or lactation
• pericoronitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. method, Edema measurement methods; The surgeon will measure from three different places on the patient's face with the help of a paper ruler to measure the edema. Tragus-Pogonion Tragus-Labial Comissura Angulus Mandible-Latheral Cantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.	Other: Edema measurement methods; A correlation between the results of the first and second methods will be examined.
No Intervention: 2. method, Edema measurement methods; Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 5 will be pointed on the scale postoperative 2. and 7. days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tragus-pogonion measurement will be made with paper ruler.	The measurement will be done on the 2. and 7. postoperative day and preoperative.	Up to 1week
Tragus-labial comissura measurement will be made with paper ruler.	The measurement will be done on the 2. and 7. postoperative day and preoperative.	Up to 1week
Angulus mandible-latheral cantus will be made with paper ruler	The measurement will be done on the 2. and 7. postoperative day and preoperative.	Up to 1week

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi
• Investigators: Principal Investigator: Dilek Menziletoglu, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: edema; third molar
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: NEU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No