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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Edema measurement methods
Sponsored by
Konya Necmettin Erbakan Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring edema, third molar

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Necmettin Erbakan University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1. method, Edema measurement methods

2. method, Edema measurement methods

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tragus-pogonion measurement will be made with paper ruler.
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Tragus-labial comissura measurement will be made with paper ruler.
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Angulus mandible-latheral cantus will be made with paper ruler
The measurement will be done on the 2. and 7. postoperative day and preoperative.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2018
Last Updated
January 3, 2019
Sponsor
Konya Necmettin Erbakan Üniversitesi
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1. Study Identification

Unique Protocol Identification Number
NCT03747237
Brief Title
Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
Official Title
Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
edema, third molar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. method, Edema measurement methods
Arm Type
Experimental
Arm Description
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.
Arm Title
2. method, Edema measurement methods
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Edema measurement methods
Intervention Description
A correlation between the results of the first and second methods will be examined.
Primary Outcome Measure Information:
Title
Tragus-pogonion measurement will be made with paper ruler.
Description
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Time Frame
Up to 1week
Title
Tragus-labial comissura measurement will be made with paper ruler.
Description
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Time Frame
Up to 1week
Title
Angulus mandible-latheral cantus will be made with paper ruler
Description
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Time Frame
Up to 1week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Menziletoglu
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University, Faculty of Dentistry
City
Konya
State/Province
Karatay
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

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

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